CLASS II Device recall · Reported 19 Aug 2015 · FDA Enforcement Report

i-Stat PT/INR Cartridges List number 03P89-24 The cartridges recalled

Abbott Point Of Care is recalling i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are, distributed nationwide in the US. The recall was initiated on 15 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.

Quantity recalled423,168 cartridges

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2361-2015
FDA event ID: 71665
Recalling firm: Abbott Point Of Care, Princeton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 15 Jun 2015
FDA classified: 10 Aug 2015
Reported: 19 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Patient Monitors

Timeline

15 Jun 2015	Recall initiated by company
10 Aug 2015	Classified by FDA	+56 days
19 Aug 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged in sealed pouches, one per pouch. There are 24 cartridges packed in a box. a prothrombin time test useful in monitoring patients receiving oral anticoagulation therapy such as coumadin or warfarin.

Where it was distributed

Worldwide Distribution - US (nationwide) and Internationally to China, Lebanon, Costa Rica, Singapore, Brazil, Jordan, Russia, Greece, Austria, India, Nigeria, United Kingdom, Korea, Saudi Arabia, Morocco, Slovenia, Portugal, Tunisia, Kazakhstn, Qatar, U.A.E. Israel, Taiwan, Mexico, Argentina, Poland, Italy, Hong Kong, Kuwait, Switzerland, Turkey, Ireland, Chile, Germany, and Australia.

Nationwide

Questions about this recall

Why was it recalled?

Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.

Which lots are affected?

All lots from S15007 to S15026 inclusive and All lots from T15037A to T15076A inclusive.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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