FDA Device recall Z-0688-2019
VITROS HBeAg Reagent, Cat
- FDA Device
- Class II
- ongoing
- Published 2019-01-09
On 2019-01-09 the FDA classified a Class II recall of VITROS HBeAg Reagent, Cat by Ortho Clinical Diagnostics, citing 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 ar….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0688-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-11-01 |
| Published | 2019-01-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus (HBV) infection using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Test results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovery from hepatitis B infection. The VITROS HBeAg test should not be used to test cord blood samples. 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
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.
Identifiers
| code_info | All expired, in-date, and future lots released. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0688-2019%22
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