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.
Reported: May 1, 2013 Initiated: November 1, 2012 #Z-1161-2013
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.
Reason for Recall
Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 1464 units
- 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.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ortho-Clinical Diagnostics. Units affected: 1464 units.
Why was this product recalled? ▼
Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2013. Severity: Low. Recall number: Z-1161-2013.
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