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Recall Observatory FDA recall evidence

Device 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).

Z-2142-2024

March 01, 2024

Class II

Product summary

Firm
Ortho-Clinical Diagnostics, Inc.
Event
Event 94679
Status
Ongoing
Classification
Class II
Quantity
481 units
Official record key
device-enforcement:Z-2142-2024

Official wording

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

Code information: 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).

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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