Drug recall
Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent…
FDA recall event 65476 · Class II · Remel Inc
Key facts
| Event ID | 65476 |
|---|---|
| Recall numbers | Z-0537-2014, Z-0538-2014 |
| Recalling firm | Remel Inc |
| Product type | Devices |
| Products | Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label…, Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The product may give weak or false negative test results. |
| Initiation date | May 2, 2013 |
| Report date | Dec 25, 2013 |
| Termination date | Mar 12, 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: