VITROS Immunodiagnostics Products HBsAg Reagent Pack…

Date posted by the FDA

April 14, 2007

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

Product

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.

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.

Distribution pattern

Worldwide Distribution --- USA including Puerto Rico and countries of Tortola (British Virgin Islands) and Anguilla.

Quantity

Cat. #6801322 (1 Reagent Pack box per sales unit): 11,761 units; Cat. #6802450 (5 Reagent Pack boxes per sales unit): 4125 units

Codes and lots

Lots 6000 and 6030 thru 6120

Recall started

Feb. 1, 2007

Device type

Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)

Root cause (FDA)

Other

What the company told customers

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 within 12 hrs. of collection. -Continue to perform supplemental testing to confirm all HBsAg results that repeat as 'Borderline' or 'Reactive', as directed in the Package Insert. - Complete and return the attached Confirmation of Receipt Form upon receipt of this notification. - Forward the information in this notification if you have distributed the product outside your facility

Recall number

Z-0747-2007

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0747-2007. The agency record governs; check it and the company before acting.