NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
Recall
- Recall Number
- Z-0738-2022
- Event Number
- 89675
- Firm
- NeuMoDx Molecular Inc
- FEI Number
- 3010729479
- Product Code
- QJR
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- January 21, 2022
- Address
- 1250 Eisenhower Pl, Ann Arbor, MI, 48108-3281
Description
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.
A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
Customers were contacted by phone 21 Jan 2022 and sent a follow up email with instructions to stop using Lot 116305 S/L02, discard remaining inventory, and review all SARS-CoV-2 positive results previously obtained using the affected product lot to exclude erroneous diagnosis and treatment. Customers are to forward this information to all individuals and departments within their organization using the affected product. If you have any questions regarding this notice, please contact QIAGEN Technical Services at 1-800-362-7737 or [email protected].
US Nationwide distribution in the states of FL, MD, MI, NY.
102 boxes