Home / Recalls / Abbott Point Of Care Inc. / Z-2157-2012

Z-2157-2012 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
August 15, 2012
Initiation Date
March 1, 2012
Termination Date
February 8, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,950,296 cartridges US; 156,408 cartridges OUS

Product Description

I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park, IL 60064 USA This cartridge is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.

Reason for Recall

The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.

Distribution Pattern

Worldwide Distribution -- (USA) nationwide

Code Information

List number 04J50-01 04J5O-02 03P89-24 Lots begininng with R11 or R12

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  • Z-1263-2020 Class II — i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Produ (January 15, 2020)
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