FDA Device recall Z-0465-2015
Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, 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 Pneumo Groups 2-14 Latex Test, DR0802M, 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-0465-2015 |
| 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 Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of predominant Legionella species grown on plate media from patients with suspected Legionellosis or from environmental sources. The test allows a separate identification of Legionella pneumophila serogroup 15 and serogroups 1-14 and detection of other pathogenic non L. pneumophila, Legionella strains.
Reason
A reagent within the test may return false negative results.
Identifiers
| code_info | DR0802M box lot 1301909, 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-0465-2015%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.