VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Reported: January 1, 2014 Initiated: October 25, 2013 #Z-0557-2014
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.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- 1,920 kits
- Distribution
- Nationwide distribution - all states.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs. Recalled by Ortho-Clinical Diagnostics. Units affected: 1,920 kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2014. Severity: Moderate. Recall number: Z-0557-2014.
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