—#116872

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.

FDA product code: GNX — Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Device class: Class 1
Medical specialty: Microbiology
Affected lot / code info: Lot 260745, exp. 5/31/2014

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

The firm, ThermoFisher Scientific, sent a "MEDICAL DEVICE RECALL" letter dated February 20, 2013 to its customers via regular mail. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory for affected product lots; discard the affected product; notify any personnel who needs to be notified of the potential for a false negative indication when using the swab, and complete and return the attached Medical Device Recall Return Response Acknowledgment & Receipt Form via Fax to: Attn: Technical Service & Regulatory Affairs at 1-877-428-1924. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).

Recalling firm

Firm: Remel Inc
Address: 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519

Distribution

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.

Timeline

Recall initiated: 2013-02-19
Posted by FDA: 2013-08-13
Terminated: 2013-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116872. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.