FDA Medical Device Recalls (openFDA)
Remel Inc: Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml tube, Catalog Number: R8325106, 20/pack, Remel, Lenexa, KS 66215
- Recall number
- Z-1625-2008
- Recalling firm
- Remel Inc
- Product
- Remel RapID Inoculation Fluid, Microorganism differentiation and identification device, Packaged in 2-ml tube, Catalog Number: R8325106, 20/pack, Remel, Lenexa, KS 66215
- Status
- Terminated
- Initiated
- 2007-10-23
- Posted
- 2008-05-14
- Terminated
- 2008-07-16
- Reason
- Failure to produce reaction: Use of the product with various RapID Identification systems panels may exhibit poor or no reactions.
- Root cause
- Other
- Action
- Consignees were notified by an Important Medical Device Customer Advisory Notice on 10/23/07. The letter instructs users to review inventory and discard any affected products. The letter also instructs users to return a product inventory checklist by 11/23/07. For additional information, contact 1-800-447-3641.
- Quantity
- 554/2-ml packs
- Distribution
- Worldwide Distribution including USA and countries of Taiwan, Japan, and U.K.
- Lot, serial or model codes
- Lot 521354
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LIB
- 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