Gibson Laboratories Inc RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative bacteria with a reduced susceptibility to most of the carbapenem agents. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative bacteria with a reduced susceptibility to most of the carbapenem agents.
Brand
Gibson Laboratories Inc
Lot Codes / Batch Numbers
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
Products Sold
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
Gibson Laboratories Inc is recalling RambaChrom KPC M/N 11500. RambaCHROM KPC is for detection of gram negative bacteria with a reduced s 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