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FDA Medical Device Recalls (openFDA)

Beckman Coulter Inc: Synchron CX (and) Synchron LX Systems Microalbumin Calibrator.

Recall number
Z-1115-04
Recalling firm
Beckman Coulter Inc
Product
Synchron CX (and) Synchron LX Systems Microalbumin Calibrator.
Status
Terminated
Initiated
2003-09-17
Posted
2004-07-20
Terminated
2004-08-30
Reason
Sample values may be decreased by between 9 and 12 percent.
Root cause
Other
Action
not on file
Quantity
NA, customer based action.
Distribution
not on file
Lot, serial or model codes
All lots.
510(k) numbers
not on file
PMA numbers
not on file
Product code
JIS
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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