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FDA Medical Device Recalls (openFDA)

Beckman Coulter Inc: Synchron LX Systems Primary Tube Sample Template (a piece of ''labeling'' for use with the Synchron LX 20 and LX 20 Pro systems). Part Number: 967178

Recall number
Z-1077-03
Recalling firm
Beckman Coulter Inc
Product
Synchron LX Systems Primary Tube Sample Template (a piece of ''labeling'' for use with the Synchron LX 20 and LX 20 Pro systems). Part Number: 967178
Status
Terminated
Initiated
2003-06-19
Posted
2003-08-06
Terminated
2004-12-01
Reason
Dead volume on sight gauge for the Synchron LX 20 and LX 20 Pro Systems not stated, which may result in instrument error.
Root cause
Other
Action
A revised template with a recall letter was sent to customers with a response request on 19 June 2003.
Quantity
502
Distribution
USA and Canada.
Lot, serial or model codes
No range of serial numbers apply.
510(k) numbers
not on file
PMA numbers
not on file
Product code
not on file
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

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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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