Coaguchek xs recall.......!

[ShezaGirlie]

Roche is recalling some of the CoaguChek XS machines. If you are affiliated with Alere and monitored through their system, you will receive a phone call and be asked to send your unit back in a pre-paid package. You will be sent a new CoaguChek XS machine..!

For Alere customers who have questions: 1-866-563-5528 for recall information if you have not received a call from them first.

I don't know if this is the same recall as: http://www.accessdata.fda.gov/scrip...lts.cfm?dls=1&q=coaguchek xs&pf=&pn=10&sc=cdd

Other customers should probably call Roche..

 

[njean]

Thanks for the info Janie!

I'm being monitored by Alere too but I have an INRatio machine. I hope they don't recall these as well!

 

[Freddie]

As I read this, it does not effect Canadians, correct?

 

[ShezaGirlie]

Freddie - if it's one of the recalls referenced above by the FDA in the USA it says: " Worldwide Distribution" - so I don't know. I suppose be safe and call Roche or your provider.

 

[Freddie]

Janie, this recall is a year old. Granted it's a good thing to know, but those who could have been effected would have already been 'stabbed' or phoned by Alere?

 

[Protimenow]

Is this the recall because the wrong cleaning product was used to clean the area under the cover? If you haven't cleaned yours yet - the meter is probably okay (if this is THAT recall).

Apparently the wrong cleaning solution did something to the meter so it got wrong results (or something)

 

[Bina]

Janie, here in Canada I haven't heard anything, and I do receive periodic mailings from Roche/Coaguchek.

The link that you posted is regarding 2 issues from 2009:

1) Packages of lancets where some of the protective caps may be missing.

2) Revised cleaning procedures for mainly the Coaguchek XS Plus system used by professionals with many different patients.
(actually I vaguely remember seeing an insert in my box of test strips regarding this, but it didn't apply to me)

 

[dick0236]

Janie, this recall is a year old. Granted it's a good thing to know, but those who could have been effected would have already been 'stabbed' or phoned by Alere?

Freddie, this is not necessarily true. I have been using a Coaguchek since 7/09 and was just notified TODAY by Alere of the recall and that they are sending me a new machine. It is alarming that it has taken a year to be notified of a potential problem.

 

[Kvntoday]

Hi Janie,
I will take your advice and send a note to Roche in New Zealand .
Thanks ......Kvntoday

 

[lance]

What a surprise!
Reading the FDA site it appears that there is a kit of some sort containing solutions/instructions that was sent to some users.
My XS came with a carrying case, strips, the meter, a Softclix and about 10 white lancettes--nothing else.
I have enough trouble at times getting enough blood so I'm not concerned about "accidental sticks caused by loose caps".
Anyway, thanks for the "heads up".

 

[ShezaGirlie]

Yes, looks like recall was initiated last year for "cleaning procedures"

Yes, looks like recall was initiated last year for "cleaning procedures"

PRODUCT
1) Roche Coaguchek XS System, Coaguchek XS Professional Care Kit; Catalog/Model Number 04837975001. Coaguchek XS System and Coaguchek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. Recall # Z-2002-2009;

2) Roche Coaguchek XS System, Coaguchek XS PST Kit; Catalog/Model Number 04837738001. Coaguchek XS System and Coaguchek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. Recall # Z-2003-2009;

3) Roche Coaguchek XS System, Coaguchek XS Plus Care Kit; Model Number 05021537001. Coaguchek XS System and Coaguchek XS Plus System are point of care monitoring devices for people taking oral anticoagulation medication. Recall # Z-2004-2009
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated July 22, 2009.
Manufacturer: Roche Diagnostics Gmbh, Mannheim, Germany. Firm initiated recall is ongoing.
REASON
The recommended cleaning procedures for the meter may cause a malfunction and falsely elevated test result reports.
VOLUME OF PRODUCT IN COMMERCE
210,000 units
DISTRIBUTION
Nationwide and Internationally
___________________________________

 

[Bina]

Janie, my memory kicked in.
When I ordered my test strips a couple of months ago I noticed the bright pink revised instruction paper in each of my test strip boxes. I was concerned when I saw that the boxes were marked for XS Pro use and I called Roche. They confirmed that during commercial use with multiple clients the cleaning procedure was a concern, but obviously that is not the case in my home. I have used the strips without issue and my INR is always in range anyway.
Apparently too many Clinics are using alcohol cleaning products and finger wipes without giving the alcohol enough time to properly evaporate.

 

[zipper2]

I didn't hear bout this Janie,
Was anyone throughout the time of getting their machine,i got mine through Roche,but the pharmacist told me to bring it in once a year
just for a (mechanical,matience check) were you told this Freddie as i recall you got yours same pharmacy i did?
Anyhow i never took my coagucheck for a check up
i'm still inr'd correctly by it.........lol be lost without it i tell you

 

[Freddie]

Well I'll be darned........Hi there Zipper2.

Yea I did buy my monitor at the same place as you. Ron did not tell me anything about bringing the monitor in after a year for a mechanical or maintenance check - and it's been a year.

 

[Protimenow]

This is not entirely related to the XS Recall - but I want to point out that the CoaguChek S, which was followed by the XS is apparently at the end of its supported life. The last strips for this machine are set to expire in October 2011 - after that, no strips wil apparently be available. I'm posting this here, just in case you know someone who is using a CoaguChek S meter.

 

[Kvntoday]

This is Historic and here is a reply frome Roche New Zealand.
Hi Kevin,



Thanks for your email enquiry.



Re the notice you’ve seen: http://www.valvereplacement.org/for...aguchek-xs-recall.......!&p=467575#post467575



This is an open forum. The posting is confusing as Alere is INRatio another INR monitor and not the CoaguChek XS.



We have received no recall notifications through Roche and I have checked the FDA website – the notifications there are historical from 2009 and relate to the new cleaning instructions and the issue with the lancing devices – both of which have been dealt with.



Kind Regards

Keryn

Regards to all .....Kevin

 

[ShezaGirlie]

Alere is more than just CoaguChek & Roche products..

Alere is more than just CoaguChek & Roche products..

Kevin,
Thanks for your info, but I'm a little confused by what Roche New Zealand said. Yes, this is a recall of the CoaguChek XS from Sept 2009, but some of us here are just now learning about it.

Alere is a worldwide company with locations around the world - http://www.alere.com/en/global-products-services.html
New Zealand
Alere Ltd
formerly Inverness Medical New Zealand Ltd.
PO Box 105653, Auckland City
Auckland 1143 New Zealand
Tel: 0800 466951
Fax: 0800466958
E-mail: [email protected]
http://www.alere.co.nz

I don't know what Roche New Zealand was talking about when they told you, "The posting is confusing as Alere is INRatio another INR monitor and not the CoaguChek XS." Kevin - what do you think they meant?

 

[Protimenow]

Janie -- Alere is the parent company for Hemosense, the manufacturers of the InRatio.

The person at Roche may not have been familiar with the monitoring services provided in the United States by Alere, and didn't realize that Alere (the old Alere?) used BOTH CoaguChek and InRatio monitors for its client testing. To this person, Alere probably MEANS InRatio.

 

[dick0236]

Alere is the parent company for Hemosense, the manufacturers of the InRatio.
.

That's interesting information. Does that mean that for those of us who use Coaguchek machines, and are in the Alere INR testing program, it will be like taking your Ford to a Toyota dealer for service:eek2:?

I hope Alere does not try to wean us off the Coaguchek XS. I have used both the INRatio and the Coaguchek XS and kinda like the Coaguchek better.....and I am getting "old" and resist "re-training":redface2:.

 

[Kvntoday]

Hey Dick,
You dont drive a "Ford" do you ?????????


Kevin