Company: Beckman Coulter, Inc
Date of Enforcement Report: 12/15/04
Class: II
PRODUCT
Access Immunoassay Systems, Discrete photometric chemistry analyzer. Recall # Z-0265-05.
REASON
A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking results may be affected. The instrument will erroneously perform the blocking calculation on the affected test by using the mean of the diluted and neat results.
CODE
Access 2 Immunoassay Systems Part Number 81600N software versions 20., 2.1, and 2.2. Access Immunoassay Systems Chlamydia Reagent Kit Part Number 34401.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on November 8, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,197 units.
DISTRIBUTION
Nationwide and Canada.
