FDA Device recall Z-1474-2014
Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box
- FDA Device
- Class II
- terminated
- Published 2014-04-30
On 2014-04-30 the FDA classified a Class II recall of Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box by Remel, citing A reagent contained within the product may return false negative results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1474-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-17 |
| Published | 2014-04-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Remel |
| Distribution | CA, FL, IL, MA, ME, NJ, PA, TN, TX, VA, VT |
Product
Oxoid Legionella Pneumo Groups 2-14, 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, DR0802. The responsible firm on the label is Oxoid Ltd., Basingstoke, Hants, England.
Reason
A reagent contained within the product may return false negative results.
Identifiers
| code_info | DR0802M box lot number 1265362, Exp. 30Jun2014; DR0802 reagent bottle lot number 1265366, exp. June, 2014 |
|---|
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-1474-2014%22
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