FDA Medical Device Recalls (openFDA)
Remel Inc: Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
- Recall number
- Z-0200-2015
- Recalling firm
- Remel Inc
- Product
- Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
- Status
- Terminated
- Initiated
- 2014-10-17
- Posted
- 2014-11-10
- Terminated
- 2017-02-13
- Reason
- Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.
- Root cause
- Under Investigation by firm
- Action
- Thermo Fisher sent an Urgent Medical Device Recall letter dated October 17, 2014, to all affected customers.
- Quantity
- 16/10/100 ml, vial, pkgs
- Distribution
- Distributed in the states of ND, VT and TX.
- Lot, serial or model codes
- Lot Number: 1451506 Expiration: 26Feb2016
- 510(k) numbers
- ["K831469"]
- PMA numbers
- not on file
- Product code
- JSK
- 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