Recall Z-1905-2021 ยท QKO Reagent, Coronavirus Serological
Beckman Coulter Inc.
Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
| Date | May 7, 2021 |
| Status | Terminated |
| Reason | SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values. |
| Root cause | Software Design Change |
| Action | On May 7, 2021, Beckman Coulter issued an "URGENT MEDICAL DEVICE RECALL" to affected consignees. The notification was emailed and sent via First Class Mail. In addition to informing consignees about the recall, the firm ask consignees to take the following actions: 1. Do not install any of the APF/AAF versions listed in the table. 2. Determine your current APF/AAF version. " From the Main Menu: select Configure F8 System Setup F1 System Revisions F1. " Verify the APF/AAF version displayed on the screen. 3 If the APF/AAF version is listed in the table: " Stop using the Access SARS-CoV-2 I |
| Quantity | 13,337 units |
| Distribution | US: Alabama, Alaska, Arizona, Arkansas, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West V |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.