FDA Device recall Z-1962-2013
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 Con…
- FDA Device
- Class III
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class III recall of 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 Con… by Remel, citing flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1962-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-02-19 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Remel |
| Distribution | US |
Product
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 pouch. The firm name on the label is Remel Europe, Ltd., Dartford, Kent, United Kingdom. Product is a test kit containing characterized positive and negative controls intended for use in qualitative procedures as external quality control material for the Remel Xpect Flu A&B test kit.
Reason
Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
Identifiers
| code_info | Lot 260745, exp. 5/31/2014 |
|---|
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-1962-2013%22
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