Recall Z-0466-2015 ยท LIB Device, General Purpose, Microbiology, Diagnostic
Remel Inc
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Latex Reagent, DR0802, Lot 1301912. The responsible firm on the label is Oxoid Ltd.
| Date | Dec 16, 2014 (initiated Oct 23, 2014) |
| Status | Terminated |
| Reason | A reagent within the test may return false negative results. |
| Root cause | Other |
| Action | ThermoFisher sent a Medical Device Recall letter dated October 23, 2014. 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 results for the affected product. Customers should review their inventory for the affected products and discard them. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed customers should contact those entitie |
| Quantity | 59/50 test boxes |
| Distribution | Nationwide Distribution including AZ, CA, DC, FL, IL, ME, NJ, NY, PA, VA, and VT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.