Recall Z-2142-2024 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
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, C3 - red).
| Date | Jun 13, 2024 (initiated Mar 1, 2024) |
| Status | Open, Classified |
| Reason | Potential for positively biased results due to signal reduction over shelf life. |
| Root cause | Under Investigation by 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 Organ |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.