Remel X/pect Flu A&B Control Swabs — Class III medical device recall Z-1962-2013
Terminated recall by Remel Inc, reported 2013-08-21, distributed nationwide. Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu
| Recall number | Z-1962-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Remel Inc, Lenexa, KS, United States |
| Recall initiated | 2013-02-19 |
| Classified | 2013-08-13 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2013-08-14 |
| Distributed | Nationwide (US) |
| Lot numbers | 260745 |
| Model numbers | R246003 |
| Expiration dates | 2014-05-31 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1962-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.