Home / Recalls / Abbott Laboratories / Z-1660-2022

Z-1660-2022 Class II Ongoing

Recalled by Abbott Laboratories — Abbott Park, IL

Recall Details

Product Type
Devices
Report Date
September 7, 2022
Initiation Date
July 26, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2451 kits of 100 tests

Product Description

ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27

Reason for Recall

One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.

Distribution Pattern

Nationwide

Code Information

UDI (01) 00380740048525 (17) 991231 (10) 12345M100 (240) 2K4127 Lot lot 63718UN22

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