Z-2498-2021 Class II Terminated
FDA device recall Z-2498-2021 was initiated by Roche Molecular Systems, Inc. on August 4, 2021 and is designated Class II. Reason for recall: Customers have reported an increased number of false positive SARS-CoV-2 results. The recall status is terminated (terminated February 23, 2024). Affected quantity: 211 kits (US); 3073 kits (OUS).
Recall Details
- Product Type
- Devices
- Report Date
- September 29, 2021
- Initiation Date
- August 4, 2021
- Termination Date
- February 23, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 211 kits (US); 3073 kits (OUS)
Product Description
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
Reason for Recall
Customers have reported an increased number of false positive SARS-CoV-2 results.
Distribution Pattern
Worldwide 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.
Code Information
Lot 10119Z