FDA Medical Device Recalls (openFDA)
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 number
- Z-0827-2010
- Recalling firm
- Gibson Laboratories Inc
- 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.
- Status
- Terminated
- Initiated
- 2009-12-17
- Posted
- 2010-02-24
- Terminated
- 2012-09-21
- Reason
- 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
- 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
- 3,440 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSO
- Firm FEI
- 1050138
- Firm city
- Lexington
- Firm state
- KY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28