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FDA Medical Device Recalls (openFDA)

Beckman Coulter Inc: Beckman Coulter 1500 Series Hematology Automation System; Part Number: 988609 (LH Basic Uint) 988610 (LH Connection Unit)

Recall number
Z-1041-05
Recalling firm
Beckman Coulter Inc
Product
Beckman Coulter 1500 Series Hematology Automation System; Part Number: 988609 (LH Basic Uint) 988610 (LH Connection Unit)
Status
Terminated
Initiated
2005-06-20
Posted
2005-07-22
Terminated
2012-03-07
Reason
Risk of injury to workers due to mechanical or electrical hazards.
Root cause
Other
Action
Letters were sent advising of the hazard during the week of June 20, 2005 it stated that the units would be upgraded by appointment.
Quantity
34
Distribution
USA and Canada
Lot, serial or model codes
NA
510(k) numbers
not on file
PMA numbers
not on file
Product code
GKZ
Firm FEI
2050012
Firm city
Brea
Firm state
CA
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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