23

Sep

2020

Recall – COVID-19 interpretive software may yield invalid results

recall, softwareerror

0

Company: Life Technologies Corporation
Date of Enforcement Report: 9/23/2020
Class II

PRODUCT

The TaqPath RT-PCR COVID-19 Kit with Applied Biosystem’s COVID-19 Interpretive Software v1.2 for 7500 RTPCR instruments, includes the assays and controls for a multiplex real-time RT-PCR test for the qualitative detection of RNA from SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. The test is interpreted by COVID-19 Interpretive Software

Recall Number: Z-2978-2020

REASON

COVID-19 Interpretive Software issues that may cause: 1) the risk of invalid or inconclusive tests/false negative and potentially increasing the retesting burden on customers. 2) false positive results due to improper vortexing.

RECALLING FIRM/MANUFACTURER

Life Technologies Corporation on 8/6/2020. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

NA

DISTRIBUTION

U.S. Nationwide and International

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