Device product
Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
Z-1232-2015
Product summary
- Firm
- Remel Inc
- Event
- Event 70471
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 packs (10 x 100 ml vials)
- Official record key
device-enforcement:Z-1232-2015
Official wording
Reason: Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
Code information: Lot No. 1545171
Distribution pattern: US Distribution to the states of : MI, ND, SC, TN, and TX.
Derived failure modes
-
Unknown
Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.