Company:Abbott Laboratories, Inc.,
Date of Enforcement Report:6/27/2007
Class:ll
PRODUCT
) ARCHITECT i2000 Processing Module, for in vitro diagnostics;
List Number 8C89-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30,
v2.60 and v3.00; Recall # Z-0950-2007;
b) ARCHITECT i2000sr Processing Module, for in vitro diagnostics;
List Number: 3M74-01; v2.10, v2.11, v2.12, v2.20, v2.20DB, v2.30,
v2.60 and v3.00; Recall # Z-0951-2007;
c) ARCHITECT c8000 Processing Module, for in vitro diagnostics;
List Number: 1G06-01; Affected software: v2.10, v2.11, v2.12,
v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall # Z-0952-2007;
d) ARCHITECT c16000 Processing Module, for in vitro diagnostics;
List Number: 3L77-01; Affected software: v2.10, v2.11, v2.12,
v2.20, v2.20DB, v2.30, v2.60 and v3.00; Recall # Z-0953-2007
REASON
One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not function correctly for assays requiring a standard sample dilution. 3) Infrequent data may be missing from automatically or manually printed reports generated on the Architect system. 4) Clinical Chemistry Assays using the Spline Math Model may be unflagged but decreased (affects both Abbott and open system assays for Architect c System).
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letters on April 30, 2007. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
3344 units
DISTRIBUTION
Nationwide and Internationally
