Remel Inc: Medical Device Recall in 2013 - (Recall #: Z-1962-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: February 19, 2013

Date Posted: August 21, 2013

Recall Number: Z-1962-2013

Event ID: 64711

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.

Status: Terminated

Product Quantity: 96 kits of 20 swab sets

Code Information:

Lot 260745, exp. 5/31/2014

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated