Recall Z-1232-2015 ยท JSK Supplement, Culture Media
Remel Inc
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.
| Date | Mar 2, 2015 (initiated Feb 5, 2015) |
| Status | Terminated |
| Reason | Use of the product may not provide adequate recovery and could result in false negative identification of Legionella pneumophila. |
| Root cause | Under Investigation by firm |
| Action | ThermoFisher Scientific sent an Urgent Medical Device Recall letter dated February 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informed the consignees of the recall and the associated risk of false negative identification of Legionella pneumophila. The consignees were instructed to notify any personnel who need to be aware of the potential for false negative id. of Legionella spp. Further, the consignees were instructed to discard any affected product remaining in their inventory and review a |
| Quantity | 24 packs (10 x 100 ml vials) |
| Distribution | US Distribution to the states of : MI, ND, SC, TN, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K831469 | LEGIONELLA CYE AGAR BASE & BCYE SUPPL Oxoid U.S.A., Inc., Jun 8, 1983 |