Devices

Device Recall VITROS AntiHBS Reagent Pack

Model / Serial
Lot #'s 6630 expiration 2/26/2013, Lot # 6740 expiration 6/18/2013 and Lot # 6750 expiration date 6/11/2013.
Product Classification
Immunology and Microbiology Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
Product Description
VITROS¿ Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs || For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
Manufacturer
Ortho-Clinical Diagnostics
1 Event
- Recall of Device Recall VITROS AntiHBS Reagent Pack

Manufacturer

Ortho-Clinical Diagnostics

Manufacturer Address
Ortho-Clinical Diagnostics, 100 Indigo Creek Dr, Rochester NY 14626-5101
Manufacturer Parent Company (2017)
The Carlyle Group LP
Source
USFDA

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