Recall Z-0891-2022— Abbott Laboratories

Name: FDA recall Z-0891-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-08

Class II · Ongoing

Class II FDA medical device recall by Abbott Laboratories, initiated 2022-03-08. It names one FDA 510(k) clearance: K042924. Product: ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.. Reason: This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU)..

Recalling firm: Abbott Laboratories
Classification: Class II
Status: Ongoing
Initiated: 2022-03-08
Firm location: Abbott Park, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K042924 — ARCHITECT STAT MYO IMMUNOASSAYFisher Diagnostics·cleared 2005-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT iSystem with STAT protocol capability when used for the quantitative determination of myoglobin in human serum and plasma.

Reason for recall

This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).

Data sourced from openFDA. This site is unofficial and independent of the FDA.