Recall – Immunoassay system experiences multiple software related failures

Company: Abbott Laboratories
Date of Enforcement Report: 12/1/2021
Class II

PRODUCT

  • ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87;
  • ARCHITECT i2000SR REF 03M74-02/3M74;
  • ARCHITECT i2000 REF 08C89-01/1G17 and 8C89

Recall Number: Z-0271-2022

  • ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25;
  • ARCHITECT c8000 REF 01G06-11/1G06;
  • ARCHITECT c16000 REF 03L77-01/3L77;

Recall Number: Z-0272-2022

REASON

Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.

RECALLING FIRM/MANUFACTURER

Abbott Laboratories on 9/29/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

20,994 systems

DISTRIBUTION

U.S. Nationwide and International

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