Z-0828-2010

RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Enterococcus...

Name: Z-0828-2010 RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Enterococcus...
Creator: Gibson Laboratories Inc
Published: 2009-12-17
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2009-12-17 / Terminated / root cause: manufacturing process

FDA source

Gibson Laboratories Inc began a recall of RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Enterococcus strains on 2009-12-17. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0828-2010
Status: Terminated
Initiated: 2009-12-17
Posted: 2010-02-24
Terminated: 2012-09-21
Recalling firm: Microbiologics, Inc.
Product: RambaChrom VRE M/N 11600. RambaCHROM VRE is for detection of Van A/ Van B vancomycin resistant Enterococcus strains.
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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."
Quantity in commerce: 15,330 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.
Product codes and lots: 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

Product code JSO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)