RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Enterococcus strains.
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-0828-2010
- Quantity
- 15,330 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 # 8256101 Exp. Date 11/21/2008; Lot # 8260028 Exp. Date 11/25/2008; Lot # 8289053 Exp. Date 12/24/2008; Lot # 8291088 Exp. Date 12/26/2008; Lot # 8308002 Exp. Date 1/12/2009; Lot # 8344022 Exp. Date 2/17/2009; Lot # 9015084 Exp. Date 3/26/2009; Lot # 9034041 Exp. Date 3/24/2009; Lot # 9043079 Exp. Date 4/23/2009; Lot # 9072081 Exp. Date 5/22/2009; Lot # 9077047 Exp. Date 5/27/2009; Lot # 9100101 Exp. Date 6/19/2009; Lot # 9128102 Exp. Date 7/17/2009; Lot # 9159001 Exp. Date 8/17/2009; Lot # 9170108 Exp. Date 8/28/2009; Lot # 9175051 Exp. Date 9/2/2009; Lot # 9196042 Exp. Date 9/23/2009; Lot # 9210041 Exp. Date 10/7/2009; Lot # 9215002 Exp. Date 10/12/2009; Lot # 9224046 Exp. Date 10/31/2009; Lot # 9240088 Exp. Date 11/6/2009; Lot # 9264003 Exp. Date 11/30/2009; Lot # 9287031 Exp. Date 12/23/2009; Lot # 9296067 Exp. Date 1/2/2010; Lot # 9315031 Exp. Date 1/20/2010; Lot # 9321020 Exp. Date 1/26/2010
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."