30
Oct
2002

Inc. Class III Beckman Coulter

0

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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