FDA Enforcement
Class II
Terminated
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.
Recall: Z-1232-2015
·
Reported March 11, 2015
Enforcement
- Recall Number
- Z-1232-2015
- Event ID
- 70471
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Remel Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 11, 2015
- Initiation Date
- February 5, 2015
- Classification Date
- March 2, 2015
- Termination Date
- February 13, 2017
- Address
- 12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States
Description
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.
Reason
Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila.
Code Info
Lot No. 1545171
Distribution
US Distribution to the states of : MI, ND, SC, TN, and TX.
Quantity
24 packs (10 x 100 ml vials)