Gibson Laboratories Inc RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Enterococcus strains. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Enterococcus strains.
Brand
Gibson Laboratories Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Gibson Laboratories Inc is recalling RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Ente due to Discrepancies between the product package label and technical insert are conflicting and may be misleading to user. The technical insert included the. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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."
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, FL, IL, IN, KY, MA, MI, MO, NY, OH, PA, VA
Page updated: Jan 10, 2026