Recall Z-1473-2014 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 Group 2-14 Latex Reagent, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
| Date | Apr 18, 2014 (initiated Mar 17, 2014) |
| Status | Terminated |
| Reason | A reagent contained within the product may return false negative results. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm initiated a recall by issuing letters dated 3/17/14 via regular mail to their customers. |
| Quantity | 72/50-test boxes |
| Distribution | Distribution was made to CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, and VT. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.