FDA Device recall Z-1688-2021
VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection…
- FDA Device
- Class II
- terminated
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection… by Ortho Clinical Diagnostics, citing ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1688-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-03 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
Reason
Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associated with the calibration, when using VITROS SARS-CoV-2 Ag Reagent Pack along with VITROS Immunodiagnostic Products SARS-CoV-2 Ag Calibrator, Lot 20.
Identifiers
| code_info | Unique Identifier: 10758750033591 Lot: 0020 |
|---|
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-1688-2021%22
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