FDA Medical Device Recalls (openFDA)
Remel Inc: Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
- Recall number
- Z-1246-2014
- Recalling firm
- Remel Inc
- Product
- Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
- Status
- Terminated
- Initiated
- 2014-02-18
- Posted
- 2014-03-20
- Terminated
- 2014-06-25
- Reason
- Some of the discs may not be impregnated with the antibiotic.
- Root cause
- Process control
- Action
- ThermoFisher sent an Urgent Medical Device Recall letter dated February 18, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false indication of resistance to Vancomycin. Customers were also instructed to review their inventory for the affected product and discard it. Customers should review results reported using this lot and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed, customers should contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) and 913-888-0939 (International). For questions regarding this recal lcall 913-895-4185.
- Quantity
- 40/5/50-disc cartridge packages
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot 1174497, exp. 2015/04
- 510(k) numbers
- ["K860153"]
- PMA numbers
- not on file
- Product code
- JTN
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- 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