FDAFDA · Food and drugs·Recall number Z-2142-2024
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).
Published June 19, 2024 · Recall initiated: March 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential for positively biased results due to signal reduction over shelf life.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Distributor
- Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WI, WV and the countries of Bermuda, Colombia, Singapore.
- Lot
- Model No. 6801926; GTIN# 10758750001699; Lot 9010 (Manufactured 13-Oct-2023; Expiry 15-Jul-2024) and 9030 (Manufactured 09-Dec-2023; Expiry 26-Aug-2024).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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