Recall Z-1161-2013 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Ortho-Clinical Diagnostics
VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
| Date | Apr 23, 2013 (initiated Nov 1, 2012) |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration. |
| Root cause | Under Investigation by firm |
| Action | Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letter dated November 1, 2012, to all affected customers via USPS. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue and discard any remaining recalled lots of VITROS Anti-HBS Reagent Packs. Foreign affiliates were informed by email on November 1, 2012, of the issue and instructed to notify their consignees of the issue and actions . On March 22, 2013, OCD sent customer letters via FedEX overnight and/or via USPS to US |
| Quantity | 1464 units |
| Distribution | Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.