FDA Device recall Z-0466-2015
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box
- FDA Device
- Class II
- terminated
- Published 2014-12-03
On 2014-12-03 the FDA classified a Class II recall of Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box by Remel, citing A reagent within the test may return false negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0466-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-23 |
| Published | 2014-12-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Remel |
| Distribution | US |
Product
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.
Reason
A reagent within the test may return false negative results.
Identifiers
| code_info | DR0800M box lot 1316151, Exp. 30Sep2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0466-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.