Company: Beckman Coulter, Inc.
Date of Enforcement Report: 10/30/02
Class: III

PRODUCT
Access 2 Immunoassay Systems — Systems Software
Versions 1.0; 1.1; 1.2; and 1.3.1. Recall # Z-0124-3.

REASON
Erroneous result flags can result on printed reports and screen displays in rare circumstances.

CODE
Product Name: Access 2 Software
Part Number: 973074
Lot Number
Software Version
212702
1.3.1

212701
1.3.1

211403
1.3

210332
1.3

210331
1.3

108609
1.2

108104
1.2

107317
1.2

106682
1.2

106447
1.2

106146
1.1

105903
1.1

105270
1.1

104958
1.1

104485
1.1

103905
1.0

103436
1.0

103010
1.0.

RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on June 12, 2002. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
442.

DISTRIBUTION
Nationwide.