Ortho-Clinical Diagnostics, Inc.: 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

Hazard

Potential for positively biased results due to signal reduction over shelf life.

Details from the source

Reason for recall: Potential for positively biased results due to signal reduction over shelf life. Distribution: 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. Quantity: 481 units Lot/code info: 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).

UPC codes

10758750001699

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.