FDA Medical Device Recalls (openFDA)
Remel Inc: Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
- Recall number
- Z-0578-2015
- Recalling firm
- Remel Inc
- Product
- Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
- Status
- Terminated
- Initiated
- 2014-11-13
- Posted
- 2014-12-12
- Terminated
- 2015-01-29
- Reason
- Use of the product could result in inadequate recovery of Legionella pneumophila which could result in false negative reporting.
- Root cause
- Under Investigation by firm
- Action
- ThermoFisher sent an Urgent Medical Device Recall letter dated November 13, 2014, to the sole customer. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be aware of the potential for false negative identification of the affected product. Review their inventory for the affected product and discard it. Customers were also instructed to completed the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If further distributed customers should contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact their Technical Services Department at 800-255-6730.
- Quantity
- 1/10/100 ml/vials/packs
- Distribution
- Nationwide Distribution to FL
- Lot, serial or model codes
- Lot number: 1374439, Exp: 31 Aug 2015
- 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