Recall Z-1161-2013— Ortho-Clinical Diagnostics
Class III · Terminated
Class III FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2012-11-01, terminated 2017-03-30. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-11-01
- Terminated
- 2017-03-30
- Firm location
- Rochester, NY, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.