Coaguchek xs test strips.recall

Help Support ValveReplacement.org:

metronome

Member
Joined
Dec 30, 2012
Messages
18
Location
Dallas/Fort Worth
Roche has issued a FDA level one re-call, the most serious. I spoke with both Rick Wilburn, owner of Wilburn Medical and a supervisor at Roche. I buy two 24 strip vials from Wilburn for $225.00. This saves a considerable amount over the 6 strip vials from Allere and others. Try $4.69 vs. $20 something per strip!! Rick believes that Roche is attempting to force home testers into test monitoring services like Allere, MDINR, Coaguchek Patient Services etal. These are basically subscription services, charging insurance and customers a recurring monthly fee. Roche confirmed this by informing me that since Wilburn isn't an "approved" FDA distributor I can longer purchase 24 strip vials.Those are only intended for healthcare professionals... HORSESH*T. I've been self-testing since 2002 and now the pull this stunt. Thankfully, Wilburn is replacing my recalled strips so I'm good till this time next year. If Roche enforces this policy I may buy a different machine...
 

pellicle

Professional Dingbat
Joined
Nov 4, 2012
Messages
6,474
Location
Queensland, OzTrayLeeYa
Hi

metronome;n885787 said:
...I buy two 24 strip vials from Wilburn for $225.00. This saves a considerable amount over the 6 strip vials from Allere and others. Try $4.69 vs. $20
this is pretty much what I do too ... although I'm an Australian who spends substantial time in Europe, so my experiences are "directed" in that manner.

Rick believes that Roche is attempting to force home testers into test monitoring services like Allere, MDINR, Coaguchek Patient Services etal.
I'm not sure I saw how that was reasoned, but if correct that's a backward step for the patients (and one giant leap for the insurance industry).

...I can longer purchase 24 strip vials.Those are only intended for healthcare professionals...
was there a "no" missing there?

I would expect that you could buy from Canada or Mexico if you so chose. When I live in Finland I buy from Germany, and in Australia from another State to that where I live.

For instance this is what I normally buy:
https://www.medshop.com.au/products/coaguchekreg-inrange-xs-pt-test-24-strips

FWIW I'm uncertain about the needs for the "recall" being a level 1 given that the wording and description of the issue does not seem to warrant that. So there may be something to your mates views.

Best Wishes
 

metronome

Member
Joined
Dec 30, 2012
Messages
18
Location
Dallas/Fort Worth
[h=1]Roche Diagnostics Recalls CoaguChek XS PT Test Strips Due to Inaccurate INR Test Results[/h]
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death [h=3]Recalled Product:[/h]
  • Name and Version: CoaguChek XS PT Test Strips
  • Lot numbers: 28124111, 28124121, 28631911, 28631921, 28631924, 28632021, 28632213, 28632312, 28632412, 29415113, 29415123, 29494221, 29494312, 29494613, 29494711, 29778721, 29779012, 29779213, 29779214, 30497213, 30497311, 30497413, 30497423, 30497515, 31404314, 31404821, 32264116, 32264212, 32264316, 32264317, 32264411, 32264421, 33045913, 33046011, 33046113, 33046312, 33046314, 33046321, 33046322, 33449612, 33449712, 33449723, 33449817
  • Models: CoaguChek XS PT Test 2x24 Strips, CoaguChek XS PT Test 6 Strips, CoaguChek XS Test 24 Tests USA
  • Manufacturing and Distribution Dates: January 12, 2018 – October 29, 2018
  • Devices Recalled in the U.S.: More than 1.1 million packages
The lot number is printed on the test strip label, which is applied to the test strip box and the test strip vial.
 

pellicle

Professional Dingbat
Joined
Nov 4, 2012
Messages
6,474
Location
Queensland, OzTrayLeeYa
metronome;n885790 said:
The previous post was copied and pasted from my recall notification. Yes, i meant "no longer" and it's a Class I recall, not Level I....
I'm sorry for saying level when I should have said class ... I didn't know there was a difference.

I assume you're referring to:
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm624822.htm

Did you also get (or read the linked on page 1) PDF?
 

Juli

Active member
Joined
Dec 27, 2015
Messages
43
Location
Oregon
metronome;n885787 said:
Roche has issued a FDA level one re-call, the most serious. I spoke with both Rick Wilburn, owner of Wilburn Medical and a supervisor at Roche. I buy two 24 strip vials from Wilburn for $225.00. This saves a considerable amount over the 6 strip vials from Allere and others. Try $4.69 vs. $20 something per strip!! Rick believes that Roche is attempting to force home testers into test monitoring services like Allere, MDINR, Coaguchek Patient Services etal. These are basically subscription services, charging insurance and customers a recurring monthly fee. Roche confirmed this by informing me that since Wilburn isn't an "approved" FDA distributor I can longer purchase 24 strip vials.Those are only intended for healthcare professionals... HORSESH*T. I've been self-testing since 2002 and now the pull this stunt. Thankfully, Wilburn is replacing my recalled strips so I'm good till this time next year. If Roche enforces this policy I may buy a different machine...
Unfortunately I can 100% confirm your statement. Roche - after two communications with them - is refusing to follow through with the FDA mandated recall actions and is is NOT replacing my test strips since I am a home tester. If you read the cases in the MAUDE database then you see that patients with actual INR values in the lower 3 range had serious misreadings (>>4 - which put them at risk if the physician adjusted the Warfarin dose) - I have no idea how Roche can even support that the problem only exists at INR values >4.5. They claim that I should go through their service - complete nonsense and not stated in the FDA announcement. I will make an entry to the MAUDE system.

Iam am also stunned that it took Roche over 10 months to realize that the new calibration is not working and caused serious issues including two reported cases of stroke (FDA database). It looks that they have serious supply issues and they will also run into legal and compliance issues on top of the financial damage. I am expecting price increases afterwards and we all will have to pay for their incompetence and carelessness.
 

Homeskillet

Well-known member
Joined
Mar 30, 2017
Messages
114
Location
OR
Soo, today I get the email from Wilburn Medical stating that they can no longer supply Roache strips for the CoaguChek XS if you are not going through a home monitoring company, that is, if you are just testing independently. What on earth?!

So now I am stuck with this brand new CoaguChek XS and have no way to acquire strips since I bought my CoaguChek off of EBay?? You have got to be kidding me? If Roache is stopping all outlets from selling the strips I assume that would include EBay also?

Have no idea what on earth I am going to do now.
 

pellicle

Professional Dingbat
Joined
Nov 4, 2012
Messages
6,474
Location
Queensland, OzTrayLeeYa
Homeskillet;n885811 said:
So now I am stuck with this brand new CoaguChek XS and have no way to acquire strips since I bought my CoaguChek off of EBay??
Have no idea what on earth I am going to do now.
Well I doubt it will dry up totally on eBay, but what about other US suppliers, Canada, Mexico ... Australia?
 

Homeskillet

Well-known member
Joined
Mar 30, 2017
Messages
114
Location
OR
pellicle;n885812 said:
Well I doubt it will dry up totally on eBay, but what about other US suppliers, Canada, Mexico ... Australia?
Actually, after I posted that above I went to eBay (an Aussie told me to do that once :)) & I ordered 48 strips just to get them in my hand before Roache stops all external vendors from selling their supplies. I do see where someone in Germany is selling them, but, of course, things get a little risky when buying from overseas sellers. Might have no other option though.
 

pellicle

Professional Dingbat
Joined
Nov 4, 2012
Messages
6,474
Location
Queensland, OzTrayLeeYa
Homeskillet;n885813 said:
Actually, after I posted that above I went to eBay (an Aussie told me to do that once :)) & I ordered 48 strips just to get them in my hand before Roache stops all external vendors from selling their supplies. I
Just be careful to not stock more than you can realistically use before they expire.

It's hard to conceive that in a nation where (supposedly) it's a free market that it's not possible to buy them or that there would be only one online shop selling them.

Discuss with your Dr and see if there is the possibility of him / her buying them and giving them to you to use.
 

Homeskillet

Well-known member
Joined
Mar 30, 2017
Messages
114
Location
OR
pellicle;n885814 said:
Just be careful to not stock more than you can realistically use before they expire.

It's hard to conceive that in a nation where (supposedly) it's a free market that it's not possible to buy them or that there would be only one online shop selling them.

Discuss with your Dr and see if there is the possibility of him / her buying them and giving them to you to use.
Ahh, good idea. Yeah, I couldn’t agree more about the free market & the good ol’ USA . Patently ridiculous IMO.
 

tom in MO

Well-known member
Joined
Jan 17, 2012
Messages
1,100
Location
MO USA
Regulated medical devices and their supply is not a free market. The players include the US FDA, test machine makers (e.g. Roche), test supply providers (e.g. Allere) and insurance companies. They collude with each other.

For example, if you go through insurance, the meter is actually free, you are paying for the strips not the meter. They won't tell you that. I learned that from my nurse and had it confirmed when I switched providers and they gave me a new free meter even though I had one at home that was only 2-years old. They wanted the old meter back, even though it was given to me for free and was the same model as the new one.

If you call Roche, a meter provider, and ask them to sell you a meter, they tell you need to go through a service since a meter requires a prescription. The insurance companies require a prescription, thus the providers and manufacturer won't sell or give you a meter w/o a prescription. However, according to the USFDA, you don't need a prescription for a INR home test machine or the test strips. The prescription requirement is not an FDA rule, but one enforced by those who control the home testing market.
 

pellicle

Professional Dingbat
Joined
Nov 4, 2012
Messages
6,474
Location
Queensland, OzTrayLeeYa
Hi

tom in MO;n885833 said:
Regulated medical devices and their supply is not a free market. The players include the US FDA, test machine makers (e.g. Roche), test supply providers (e.g. Allere) and insurance companies. They collude with each other.
agreed ... imagine if they attempted to do that with blood sugar monitors ... but then there are far more diabetics already used to self monitoring there would be a political uproar. There's only a few (usually feeble) AC patients in contrast, why not target them?

For example, if you go through insurance, the meter is actually free, you are paying for the strips not the meter.
I'd prefer to look at it as "not specifically billed for" ... and anyone who falls for that is thinking short term or not thinking deeply (not that I'm saying that of you).

They won't tell you that.
Would you need to even ask? Anyone who thinks anything given to them by a company is "free" isn't smart.

Its interesting that the USA has a system which regulates the supply of things like blood coagulation testing systems, claims it may be dangerous when misused (although the company provides clear guidelines that you should seek supplementary tests if the range seems odd), but then the system wants that solely to be in the hands of big business.

From where I sit if you've been testing for a while and you see that your reading is WAY off with the same dose it would be prudent to go get another test "to clarify this" ... its what I'd do.

I suppose its good that they regulate such dangerous devices (potentially deadly) so strictly (although blood sugar meters for diabetics seems to be a similar regulated medical device), or harm could come to individuals. Its not like they allow you to go get a tool which would cause harm to many others instead of just yourself.




What could go wrong?
 

pellicle

Professional Dingbat
Joined
Nov 4, 2012
Messages
6,474
Location
Queensland, OzTrayLeeYa
PS: disclosure. I'm a licensed weapons holder in Australia and I fully agree with and support our weapons regulation system. Anyone seeking a good model for regulatory change in their own country should examine the Australian (State based) system as well as the Finnish National system) for a good working model.
 

Latest posts

Top