Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation
FDA device recall Z-0200-2015 · posted 2014-11-10 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- Recalled product may not provide adequate recovery of Legionella pneumophila when used as directed and may result in false negative identification of Legionella pneumophila.
- Action taken
- Thermo Fisher sent an Urgent Medical Device Recall letter dated October 17, 2014, to all affected customers.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JSK
- Quantity affected
- 16/10/100 ml, vial, pkgs
- Distribution
- Distributed in the states of ND, VT and TX.
- Date initiated
- 2014-10-17
- Date posted
- 2014-11-10
- Date terminated
- 2017-02-13
- Location
- Lenexa, KS
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEGIONELLA CYE AGAR BASE & BCYE SUPPL (K831469) | Oxoid U.S.A., Inc. | 1983-06-08 |