Recall Z-2142-2024— Ortho-Clinical Diagnostics, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2024-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).. Reason: Potential for positively biased results due to signal reduction over shelf life..
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-01
- Firm location
- Rochester, NY, United States
Product description
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
Reason for recall
Potential for positively biased results due to signal reduction over shelf life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.