Z-0688-2019 Class II Ongoing
FDA device recall Z-0688-2019 was initiated by ORTHO-CLINICAL DIAGNOSTICS on Nov 1, 2018 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 3725 units (100 tests/unit).
Recall Details
- Product Type
- Devices
- Report Date
- Jan 9, 2019
- Initiation Date
- Nov 1, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3725 units (100 tests/unit)
Product Description
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 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.
Distribution Pattern
Worldwide Distribution - US Nationwide domestic distribution. International distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, India, France, Japan, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
Code Information
All expired, in-date, and future lots released.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0688-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026