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Terminated

Synchron Liquid Comprehensive Chemistry Control Serum. Part numbers: 660710, 657365.

FDA Recall Z-1151-04 · Posted 2004-07-23

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeLEH
Date Initiated2003-04-01
Date Terminated2004-08-30
Product Quantity9730

Reason for Recall

The quality control samples for Vancomycin would not recover correctly when compared to the S.I. unit values listed in the incorrectly printed product insert. The incorrectly printed values were higher than they should be by a factor of 3 (three).

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013235MODIFICATION TO SYNCHRON CONTROLBeckman Coulter, Inc. · 2001-10-16

Official Source

View FDA Recall →

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

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