VITROS CoV2 Ag calibrator — Class II medical device recall Z-1688-2021
Terminated recall by Ortho-Clinical Diagnostics, INc., reported 2021-06-02, distributed nationwide. Ortho investigated and confirmed the potential for unexpected failed calibration, and condition codes associat
| Recall number | Z-1688-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, INc., Rochester, NY, United States |
| Recall initiated | 2021-05-03 |
| Classified | 2021-05-27 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2023-10-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | CO, ES, FR, IN, IT, JP, PT |
| Quantity | 74 units |
| UPC / GTIN / UDI-DI | 10758750033591 |
| Lot numbers | 0020 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1688-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.