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Terminated

SYNCHRON Systems Vancomycin Reagent, in vitro diagnostic. Part Number 474824.

FDA Recall Z-0886-06 · Posted 2006-05-18

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeLEH
Date Initiated2006-03-30
Date Terminated2012-02-29
Product Quantity3147

Reason for Recall

Beckman Coulter has received reports of patient samples and quality control recovery shifting low when using Vancomycin reagent lots M507219 and M511327. Internal QC recovery was as much as 15% lower than the assigned target value.

Firm Action

A Product Corrective Action (PCA) letter was be sent the week of MAR 30, 2006 to all SYNCHRON Systems Vancomycin Reagent customers of lot numbers M507219 and M511327 informing them to discontinue use and discard reagent. (Letters were sent by US mail)

Root Cause

Other

Distribution Pattern

Nationwide & Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013076SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATORBeckman Coulter, Inc. · 2001-12-12

Official Source

View FDA Recall →

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

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