Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Remel X/pect Flu A&B Control Swabs Recalled by Remel Inc Due to Flu A+ Control Swabs incorrectly give Flu A-...

Date: February 19, 2013
Company: Remel Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Remel Inc directly.

Affected 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 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.

Quantity: 96 kits of 20 swab sets

Why Was This Recalled?

Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Remel Inc

Remel Inc has 70 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report