VITROS Anti-HBe Reagent Pack — Class II medical device recall Z-0687-2019
Ongoing recall by ORTHO-CLINICAL DIAGNOSTICS, reported 2019-01-09, distributed nationwide. The firm is extending their previous July 2018 recall to include additional product codes. Biased results may
| Recall number | Z-0687-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ORTHO-CLINICAL DIAGNOSTICS, Bridgend, N/A, United Kingdom |
| Recall initiated | 2018-11-01 |
| Classified | 2019-01-03 |
| Reported by FDA | 2019-01-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BM, BR, CA, CL, CN, CO, DE, DK, ES, FR, GB, IN, IT, JP, MX, NL, NO, PL, PT, RU, SE, SG |
| Model numbers | 6801816 |
Product
VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.
Reason for recall
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
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-0687-2019. 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.