FDA Device recall Z-1906-2021
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
- FDA Device
- Class II
- terminated
- Published 2021-06-30
On 2021-06-30 the FDA classified a Class II recall of Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 by Beckman Coulter, citing 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 result….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1906-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-07 |
| Published | 2021-06-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Beckman Coulter |
| Distribution | AK, AL, AR, AZ, CA, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MO, MS, ND, NH, NJ, NY, OH, OK, PA, PR, TN, TX, VA, WI, WV, WY |
Product
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751
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.
Identifiers
| code_info | All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1906-2021%22
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