VITROS Immunodiagnostics Products HBsAg Reagent Pack, Catalog # 6801322: 1 Reagent Pack box per sales unit (100 tests pe

FDA device recall Z-0747-2007 · posted 2007-04-14 · Terminated

Recall details

Recalling firm

Ortho-Clinical Diagnostics

Reason for recall

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.

Action taken

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

Root cause

Other

Status

Terminated

Product code

LOM

Quantity affected

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

Distribution

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

Date initiated

2007-02-01

Date posted

2007-04-14

Date terminated

2012-08-03

Location

Cardiff, United Kingdom