PT/INR home testing

[iriskkerry]

Has anyone heard anything about an FDA recall on the INRATIO machine????? I cannot find anything on the web about it and I LOVE that machine but my boss told me this morning I cannot use it anymore???????

[annaedRN, RN]

Haven't heard anything about the recall..but I am SO envious - we still do them the old-fashioned way:cry:

[DriBak]

We never fielded those, we went with the Coagucheck S

[DriBak]

http://www.qualityassuredservices.com/contact.aspx

[DriBak]

I just called Hemosense, makers of the INRatio, they denied any recall at all

Tech Support Phone #:

1-877-436-6444 x4

Tech Support Email:

[email protected]

Have your manager call to confirm. We are in the process of transitioning to the INRatio NOW as it is much more cost effective than the Coagucheck S.

We have 9 Coaguchecks and are beta testing the INRatio, we have not fielded the INRatio yet and your post made me call.

[Protimeguy]

Yes there is a brand new recall on INRatio 2. You can go to CMS or google INRatio recall.

I think Roche & ITC will make a deal to help get everybody out of those machines

[HmarieD]

I contacted Quality Assured Services as listed above by another poster, and received the response that there was a "small recall" on INRatio 2 that came out in September 2008. There was one batch of meters that had the wrong size memory chip. Even so, most of the meters worked fine, but if not it would give an error message and not allow you to run a test. My impression was that this has been resolved.

[Protimeguy]

You know of course that QAS is owned by the same company that owns the INRatio. But here is the new recall,it is limitedto a 1000 or so units

The FDA has announced a class III device recall for the HemoSense INRatio2 Prothrombin Time Monitor. Per the FDA, a class III recall is defined as " not very likely to cause adverse health consequences, but there is still a chance and therefore the product is being recalled." The information below was distributed as part of the FDA's 6/3/2009 Enforcement Report.

PRODUCT

HemoSense INRatio2 Prothrombin Time Monitor. The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. Recall # Z-1256-2009

CODE

Product Numbers: 0200431 and 0200432

RECALLING FIRM/MANUFACTURER

HemoSense Inc San Jose, CA, by letter dated December 19, 2008. Firm initiated recall is ongoing.

REASON

INRaTio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result.

VOLUME OF PRODUCT IN COMMERCE

921 units

DISTRIBUTION

Nationwide, Germany, Spain and Australia