Recall Z-0747-2007 ยท LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Ortho-Clinical Diagnostics
VITROS Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests per box), and Catalog # 6802450: 5 Reagent Pack boxes per sales unit (100 tests per box), IVD. Ortho-Clinical Diagnostics Amersham UK.
| Date | Apr 14, 2007 (initiated Feb 1, 2007) |
| Status | Terminated |
| Reason | Complaints of an increase in ''Reactive'' results with patient samples collected in sodium citrate or EDTA plasma collection tubes when using these lots of VITROS HBsAg Reagent Pack compared to samples collected in other tube types. |
| Root cause | Other |
| Action | On 2/01/07, all US end-user consignees who received the VITROS HBsAg Reagent Packs, were informed of this issue by Federal Express overnight letter, and informed that they may continue to use their current lot of VITROS HBsAg Reagent Pack providing that they followed the instructions in the letter. INSTRUCTIONS: Please do the following if you choose to continue using sodium citrate and/or EDTA plasma collection tubes: - Do not freeze samples collected in sodium citrate or EDTA plasma collection tubes prior to processing the assay. - Process samples collected into sodium citrate plasma tubes wi |
| Quantity | Cat. #6801322 (1 Reagent Pack box per sales unit): 11,761 units; Cat. #6802450 (5 Reagent Pack boxes per sales unit): 41 |
| Distribution | Worldwide Distribution --- USA including Puerto Rico and countries of Tortola (British Virgin Islands) and Anguilla. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.