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Roche Molecular Systems, Inc. Recall 88600

Description: cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190

Roche Molecular Systems, Inc. Recall 88600 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2498-2021
Event ID88600
Event Descriptioncobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution in the states of AR, CA, IL, IN, KS, ME, MI, MN, MO, NY, OR, TN, TX, WA, and WI. The countries of Canada, UK, Austria, Belgium, Croatia, Denmark, Finland, France, Germany, Netherlands, Norway, Poland, Slovakia, and Spain.
Quantity211 kits (US); 3073 kits (OUS)
Recall ReasonCustomers have reported an increased number of false positive SARS-CoV-2 results.
Device Classification20210929
Device Code InfoLot 10119Z
Center Classification Date20210921
Recall Initiation Date20210804
Recalling FirmRoche Molecular Systems, Inc.
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