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).
FDA Recall Z-2142-2024 · Posted 2024-06-13
Advertisement
Recalling FirmOrtho-Clinical Diagnostics, Inc.
Recall StatusOpen, Classified
Product CodeLOM
Date Initiated2024-03-01
Product Quantity481 units
Reason for Recall
Potential for positively biased results due to signal reduction over shelf life.
Firm Action
Consignees were mailed an URGENT PRODUCT CORRECTION NOTIFICATION, dated 5/14/24. In this notice consignees are instructed to discontinue using, render unusable, and discard affected product. The provided notification is to be retained and posted by each VITROS System until the issue has been resolved; copies of the recall notification are to be forwarded if affected product was distributed outside your facility. Consignees are to complete and return the provided Confirmation of Receipt form no later than 5/22/24. Consignees with any questions are to contact Quidel Ortho's Global Services Organization at 1-800-421-3311.
Root Cause
Under Investigation by firm
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement