Oxoid Legionella Latex Test — Class II medical device recall Z-0466-2015
Terminated recall by Remel Inc, reported 2014-12-03, distributed nationwide. A reagent within the test may return false negative results.
| Recall number | Z-0466-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2014-10-23 |
| Classified | 2014-11-25 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2015-01-22 |
| Distributed | Nationwide (US) |
| Lot numbers | 1301912, 1316151 |
| Expiration dates | 2014-09-30 |
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 for recall
A reagent within the test may return false negative results.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0466-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.