VITROS Anti-SARS-CoV-2 IgG Reagent Pack — Class II medical device recall Z-2771-2020
Terminated recall by Ortho Clinical Diagnostics, reported 2020-08-19, distributed nationwide. The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delaye
| Recall number | Z-2771-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2020-07-17 |
| Classified | 2020-08-07 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2021-07-16 |
| Distributed | Nationwide (US) |
| Quantity | 2,349 sales |
| UPC / GTIN / UDI-DI | 10758750033355 |
| Lot numbers | 0010, 0013 |
| Model numbers | 6199919 |
Product
VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
Reason for recall
The reagent bottles may be swapped within the reagent pack, which may lead to false negative results or delayed results due to calibration failures, or quality control failures.
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-2771-2020. 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.