FDA Medical Device Recalls (openFDA)
Remel Inc: remel THIOGLYCOLLATE MEDIUM, REF 05152
- Recall number
- Z-3019-2018
- Recalling firm
- Remel Inc
- Product
- remel THIOGLYCOLLATE MEDIUM, REF 05152
- Status
- Terminated
- Initiated
- 2018-08-13
- Posted
- not on file
- Terminated
- 2019-06-18
- Reason
- Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
- Root cause
- Under Investigation by firm
- Action
- The firm initiated the recall by letter on 08/13/2018. The firm directed the consignee to you inspect their stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. They also requested that the consignee review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action. The firm instructed the consignee to further distribute the notice to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For questions, please contact Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).
- Quantity
- 48 units
- Distribution
- US, Canada, Singapore
- Lot, serial or model codes
- Lot number: 258192
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSG
- 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