27
Jul
2005

Class II Beckman Coulter Inc

0

Company: Beckman Coulter Inc,
Date of Enforcement Report: 7/27/05
Class: II

PRODUCT
Beckman Coulter 1500 Series Hematology Automation System; Part Number: 988609 (LH Basic Unit) 988610 (LH Connection Unit), Recall # Z-1041-05

REASON
Risk of injury to workers due to mechanical or electrical hazards. Corrective action will include shields, covers, software interlocks, a spill tray, and edge smoothing.

CODE
N/A

RECALLING FIRM
Beckman Coulter Inc, Brea, CA, by letters on or about June 20, 2005. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
34

DISTRIBUTION
Nationwide and Canada

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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