Remel Inc recalls Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Sw

Recalled August 21, 2013 · FDA recall Z-1962-2013 · Remel

Hazard

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

Units

96 kits of 20 swab sets

Sold at

Nationwide distribution: AL, AR, CA, CO, CT, FL, GA, IA, IL, KS, MA, MD, MI, MO, NM, NV, NY, OH, PA, TX, WA, and WI.

Description

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

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.

Manufacturer(s)

Remel Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →