Home / Recalls / Abbott Point Of Care Inc. / Z-0451-2014

Z-0451-2014 Class II Terminated

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

FDA device recall Z-0451-2014 was initiated by Abbott Point Of Care Inc. on October 28, 2013 and is designated Class II. Reason for recall: Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR. The recall status is terminated (terminated May 29, 2014). Affected quantity: 794,928 units US; 119,472 units OUS.

Recall Details

Product Type
Devices
Report Date
December 11, 2013
Initiation Date
October 28, 2013
Termination Date
May 29, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
794,928 units US; 119,472 units OUS

Product Description

Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540 The i-Stat PT a prothrombin time test is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or Warfarin. The cartridge is to be used with the i-Stat 1 Analyzer and as part of the i-Stat System, the PT/INR test is to be used by trained health care professionals in accordance with a facility's policies and procedures.

Reason for Recall

Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Brazil, Chile, China, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, South Korea, Kuwait, Mexico, Netherland, New Zealand, Nigeria, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, south Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE, and United Kingdom,

Code Information

K020355 List number 04J50-01, 04J50-02; 03P89-24 Lot number R13149A; R13151; R13151A and cartridge lots from C13139 up to and including C13270A

Other recalls by Abbott Point Of Care Inc.

  • Z-2000-2026 Class II — i-STAT EG6+ cartridge; List Number: 03P77-25; (April 1, 2026)
  • Z-2001-2026 Class II — i-STAT G3+ cartridge; List Number: 03P78-26; (April 1, 2026)
  • Z-1999-2026 Class II — i-STAT EG7+ cartridge; List Number: 03P76-25; (April 1, 2026)
  • Z-2583-2025 Class II — i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940 (August 21, 2025)
  • Z-2585-2025 Class II — i-STAT EG6+ cartridge. List Number: 03P77-25. (August 21, 2025)
  • Z-2584-2025 Class II — i-STAT EG7+ cartridge. List Number: 03P76-25. (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