ARCHITECT Folate Reagent, for in vitro diagnostics, List Numbers 07K60-20 (4 x 100 test kits), 07K60-25 (100 test kits)a

FDA device recall Z-0792-2007 · posted 2007-05-09 · Terminated

Recall details

Recalling firm

Abbott Laboratories, Inc

Reason for recall

If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.

Action taken

Notification Letters were sent to all customers who received the ARCHITECT Folate Reagent on 03/28/07. Customers were provided with instructions on how to conduct a Wash Buffer Unload procedure and were requested to perform this action daily. Customers were also asked to contact their local Abbott Customer Support Rep to schedule an Internal Decontamination procedure on the ARCHITECT System. Firm recalling to the user (laboratory) level.

Root cause

Other

Status

Terminated

Product code

CGN

Quantity affected

3866 units.

Distribution

Folate Reagent distributed to the following countries: Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic

Date initiated

2007-03-28

Date posted

2007-05-09

Date terminated

2007-09-25

Location

Irving, TX