Apr

2020

Recall – Immunoassay system software issues identified

Company: Abbott Gmbh & Co. KG
Date of Enforcement Report: 4/1/2020
Class II

PRODUCT

LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.

Recall Number: Z-1580-2020

REASON

Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.

RECALLING FIRM/MANUFACTURER

Abbott Gmbh & Co. KG on 1/24/2020. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

2676 units

DISTRIBUTION

US Nationwide and International

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Recall – Immunoassay system software issues identified

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