Recall Z-2142-2024
Ortho-Clinical Diagnostics, Inc. · initiated March 1, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: 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).
Reason for recall
Potential for positively biased results due to signal reduction over shelf life.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2142-2024
- Initiated
- March 1, 2024
- Posted by FDA
- June 13, 2024
- Product code
- LOM – Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- Quantity
- 481 units
- 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.
- Recalling firm
- Ortho-Clinical Diagnostics, Inc., Rochester, NY