Recall Z-0578-2015 ยท JSK Supplement, Culture Media
Remel Inc
Oxoid Legionella BCYE Growth Supplement packaged in packs of 10-100ml vials. A growth supplement for the isolation of Legionella.
| Date | Dec 12, 2014 (initiated Nov 13, 2014) |
| Status | Terminated |
| 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 distribu |
| Quantity | 1/10/100 ml/vials/packs |
| Distribution | Nationwide Distribution to FL |
| 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 |