Company: Abbott Laboratories,
Date of Enforcement Report:7/12/2006
Class:lIl

PRODUCT
ARCHITECT B12 Reagent, list 06C09-22 (4 x 100 tests), 06C09-27 (1 x 100 tests); an in vitro diagnostic kit consisting of microparticles, conjugate, assay diluent, pre-treatment 1, pre-treatment 2, and pre-treatment 3, Recall # Z-860-06

REASON
The 30-day onboard storage information is not included in the barcode labels for these two lots. As a result, the ARCHITECT system software is unable to track how long a reagent kit has been stored onboard the ARCHITECT instrument.

CODE
Lot numbers 33079M200, 33079M201

RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letter on March 8, 2006. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
135 kits

DISTRIBUTION
Canada, Germany and Australia