FDA Medical Device Recalls (openFDA)
Remel Inc: Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
- Recall number
- Z-1921-2016
- Recalling firm
- Remel Inc
- Product
- Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
- Status
- Terminated
- Initiated
- 2016-03-24
- Posted
- not on file
- Terminated
- 2017-02-13
- Reason
- Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
- Root cause
- Under Investigation by firm
- Action
- Customers were notified by letter beginning on March 24, 2016.
- Quantity
- 2 units were imported and distributed domestically
- Distribution
- US distribution in MO.
- Lot, serial or model codes
- Lot 1717357 Exp: 31Aug2017
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JTT
- 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