Drug recall
Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A…
FDA recall event 64711 · Class III · Remel Inc
Key facts
| Event ID | 64711 |
|---|---|
| Recall numbers | Z-1962-2013 |
| Recalling firm | Remel Inc |
| Product type | Devices |
| Products | Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swabs and 20 Flu B Control Swabs, each swab is individually packaged in a foil… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit. |
| Initiation date | Feb 19, 2013 |
| Report date | Aug 21, 2013 |
| Termination date | Aug 14, 2013 |
| 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: