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Terminated

RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Enterococcus strains.

FDA Recall Z-0828-2010 · Posted 2010-02-24

Recalling FirmGibson Laboratories Inc
Recall StatusTerminated
Product CodeJSO
Date Initiated2009-12-17
Date Terminated2012-09-21
Product Quantity15,330 units

Reason for Recall

Discrepancies between the product package label and technical insert are conflicting and may be misleading to user. The technical insert included the statement for In Vitro Diagnostic Use. The product insert should have indicated for Research Use Only instead of for In Vitro Diagnostic Use.

Firm Action

On 12/10/2009 the firm sent letters to their customers notifying them of the problem and instructing them to replace insert with a new one. They were also instructed to complete and return a "Recall Response Form."

Root Cause

Employee error

Distribution Pattern

Distribution of the product was limited to AL, FL, IL, KY, MA, MI, MO, NY, OH, PA, & VA and one customer in France.

Official Source

View FDA Recall →

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

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