Recall Z-1670-2021 ยท QKP Coronavirus Antigen Detection Test System.
Beckman Coulter Inc.
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
| Date | Apr 14, 2021 |
| Status | Terminated |
| Reason | specimens collected in transport media may result is false negative results when stored in certain conditions. |
| Root cause | Unknown/Undetermined by firm |
| Action | On 4/14/2021, Becman Coulter issued an "Urgent Medical Device Recall" notice to all affected consignees via mail and E-Mail. In addition to informing consignees about the recall, the firm ask consignees to take the following actions: 1. Review the laboratory storage conditions for nasopharyngeal or nasal specimens that are collected in Bartels FlexTrans" and Sigma Virocult transport media. Evaluate the specimen storage conditions before and after extraction. 2 Review test results in the context of a patients history and clinical presentation for any specimens that were not stored according t |
| Quantity | 1,034 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, Arkansas, California, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, New Hampshire, New Jersey, New York, North |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.