Z-0687-2019 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 9, 2019
- Initiation Date
- November 1, 2018
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3429 units (100 tests per unit)
Product Description
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.
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.