Home / Recalls / Abbott Point Of Care Inc. / Z-2361-2015

Z-2361-2015 Class II Terminated

Recalled by Abbott Point Of Care Inc. — Princeton, NJ

FDA device recall Z-2361-2015 was initiated by Abbott Point Of Care Inc. on June 15, 2015 and is designated Class II. 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. The recall status is terminated (terminated February 19, 2016). Affected quantity: 423,168 cartridges.

Recall Details

Product Type
Devices
Report Date
August 19, 2015
Initiation Date
June 15, 2015
Termination Date
February 19, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
423,168 cartridges

Product Description

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.

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.

Distribution Pattern

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.

Code Information

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

Other recalls by Abbott Point Of Care Inc.

  • Z-2001-2026 Class II — i-STAT G3+ cartridge; List Number: 03P78-26; (April 1, 2026)
  • Z-2000-2026 Class II — i-STAT EG6+ cartridge; List Number: 03P77-25; (April 1, 2026)
  • Z-1999-2026 Class II — i-STAT EG7+ cartridge; List Number: 03P76-25; (April 1, 2026)
  • Z-2584-2025 Class II — i-STAT EG7+ cartridge. List Number: 03P76-25. (August 21, 2025)
  • Z-2585-2025 Class II — i-STAT EG6+ cartridge. List Number: 03P77-25. (August 21, 2025)
  • Z-2583-2025 Class II — i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940 (August 21, 2025)
  • Z-2582-2025 Class II — i-STAT CG4+ cartridge (white). List Number: 03P85-25. (August 21, 2025)
  • Z-0880-2021 Class II — Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sod (December 22, 2020)
  • Z-0881-2021 Class II — Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of (December 22, 2020)
  • Z-1262-2020 Class II — i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Pr (January 15, 2020)

FDA data resources