Mar

2022

Recall – Software error leads to incorrect immunoassay wash cycle

Company: Abbott Laboratories, Inc
Date of Enforcement Report: 3/23/2022
Class II

PRODUCT

Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specific antigens and antibodies by using chemiluminescent immunoassay technology.

Recall Number: Z-0749-2022

REASON

Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.

RECALLING FIRM/MANUFACTURER

Abbott Laboratories, Inc on 2/3/2022. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

306 units

DISTRIBUTION

U.S. Nationwide and International

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Recall – Software error leads to incorrect immunoassay wash cycle

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