Drug recall
Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box. The box contains a variety of components…
FDA recall event 67777 · Class II · Remel Inc
Key facts
| Event ID | 67777 |
|---|---|
| Recall numbers | Z-1473-2014, Z-1474-2014 |
| Recalling firm | Remel Inc |
| Product type | Devices |
| Products | 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…, 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A reagent contained within the product may return false negative results. |
| Initiation date | Mar 17, 2014 |
| Report date | Apr 30, 2014 |
| Termination date | Dec 11, 2014 |
| City | Lenexa |
| State | KS |
| Country | United States |
| FEI number | 1924669 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: