Recall Z-0271-2022— Abbott Laboratories

Name: FDA recall Z-0271-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-29

Class II · Ongoing

Class II FDA medical device recall by Abbott Laboratories, initiated 2021-09-29. It names one FDA 510(k) clearance: K983212. Product: ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89. 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: Abbott Laboratories
Classification: Class II
Status: Ongoing
Initiated: 2021-09-29
Firm location: Irving, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K983212 — ABBOTT ARCHITECT TESTOSTERONEAbbott Laboratories·cleared 1998-11-18

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

Reason for recall

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.

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