Recall Z-0557-2014— Ortho-Clinical Diagnostics
Class II · Terminated
Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-10-25, terminated 2018-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs. Reason: Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results..
- Recalling firm
- Ortho-Clinical Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-25
- Terminated
- 2018-05-18
- Firm location
- Rochester, NY, United States
Product description
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Reason for recall
Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.