FDA Medical Device Recalls (openFDA)
Remel Inc: Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033
- Recall number
- Z-1400-2017
- Recalling firm
- Remel Inc
- Product
- Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033,
- Status
- Terminated
- Initiated
- 2017-02-09
- Posted
- not on file
- Terminated
- 2019-05-01
- Reason
- Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests.
- Root cause
- Nonconforming Material/Component
- Action
- Thermo Fisher sent an Urgent Medical Device Recall letter dated February 9, 2017, to all affected customers. The recalling firm issued written notifications to their customers. Customers were instructed to destroy any remaining inventory of the recalled lots. Customers were also instructed to contact everyone within their organization or any other organization where the devices have been transferred. An acknowledgement form was included with the recall notice. Customers were asked to complete the acknowledgement form and return it to the recalling firm. If you have any questions, please contact our Technical Service Department at (800) 255-6730 ( US ) or (913) 888-0939 ( International) For further questions, please call (913) 895-4077.
- Quantity
- RO4033 - 163, R01503 - 50.
- Distribution
- USA ( nationwide ) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and WY.
- Lot, serial or model codes
- A) Lot: 978596, 2017-01-30; B) Lot: 978948, 2017/01/30
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LKA
- 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