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Terminated

Synchron Systems Lipid Calibrator (HDLD) Part 650218

FDA Recall Z-1153-04 · Posted 2004-07-23

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeJIS
Date Initiated2003-10-03
Date Terminated2004-08-30
Product Quantity2069

Reason for Recall

Incorrect units are printed in labeling but not in software.

Firm Action

Letter was mailed which explains tha the units on the Value Sheet are printed incorrectly. Recall is complete.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983640SYNCHRON SYSTEMS LIPID CALIBRATORBeckman Coulter, Inc. · 1998-12-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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