RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative bacteria with a reduced susceptibility to mos
FDA device recall Z-0827-2010 · posted 2010-02-24 · Terminated
Recall details
- Recalling firm
- Gibson Laboratories Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- JSO
- Quantity affected
- 3,440 units
- Distribution
- Distribution of the product was limited to AL, FL, IL, KY, MA, MI, MO, NY, OH, PA, & VA and one customer in France.
- Date initiated
- 2009-12-17
- Date posted
- 2010-02-24
- Date terminated
- 2012-09-21
- Location
- Lexington, KY
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