Abbott Laboratories: Medical Device Recall in 2022 - (Recall #: Z-1660-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 26, 2022

Date Posted: September 7, 2022

Recall Number: Z-1660-2022

Event ID: 90692

Reason for Recall:

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

Status: Ongoing

Product Quantity: 2451 kits of 100 tests

Code Information:

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

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated