Recall Z-2256-2021 ยท QKP Coronavirus Antigen Detection Test System.
Beckman Coulter Inc.
Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
| Date | Jul 1, 2021 |
| Status | Terminated |
| Reason | SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis . |
| Root cause | Other |
| Action | On 07/09/2021 Beckman Coulter issued an "URGENT MEDICAL DEVICE RECALL" to all affected consignees via email and US Postal Mail. In addition to informing consignees about the recalled device, the firm ask consignees to take the following actions: 1. Immediately discontinue using the Access SARS-CoV-2 Antigen assay. 2. Discard all Access SARS-CoV-2 Antigen reagent packs. 3. At the discretion of the Laboratory Medical Director, consider updating previous laboratory reports to indicate prior Reactive laboratory results may not be accurate. 4. Please share this information with your laboratory s |
| Quantity | 451 units |
| Distribution | US Nationwide Distribution in the states of Alabama Alaska 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 Carolina Ohio Oklahoma Oregon Pennsylv |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.