RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative bacteria with a reduced susceptibility to most of the carbapenem agents.
This recall has been terminated (originally issued February 24, 2010).
- Company
- Gibson Laboratories Inc
- Recall Initiated
- December 17, 2009
- Posted
- February 24, 2010
- Terminated
- September 21, 2012
- Recall Number
- Z-0827-2010
- Quantity
- 3,440 units
- Firm Location
- Lexington, KY
- Official Source
- View on FDA website ↗
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.
Distribution
Distribution of the product was limited to AL, FL, IL, KY, MA, MI, MO, NY, OH, PA, & VA and one customer in France.
Lot / Code Info
Lot# 8273017 Exp. Date 11/18/2008; Lot# 8357002 Exp. Date 2/9/2009; Lot# 9099062 Exp. Date 5/28/2009; Lot# 9121097 Exp. Date 6/19/2009; Lot# 9132038 Exp. Date 6/30/2009; Lot# 9134085 Exp. Date 7/2/2009; Lot# 9139025 Exp. Date 7/7/2009; Lot# 9166026 Exp. Date 8/3/2009; Lot# 9177131 Exp. Date 8/14/2009; Lot# 9194004 Exp. Date 8/31/2009; Lot# 9212080 Exp. Date 9/18/2009; Lot# 9222002 Exp. Date 9/28/2009; Lot# 9232053 Exp. Date 10/8/2009; Lot# 9275097 Exp. Date 11/20/2009; Lot# 9288050 Exp. Date 12/3/2009; Lot# 9306001 Exp. Date 12/21/2009; Lot# 9322047 Exp. Date 1/6/2010
Root Cause
Employee error
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."