Device 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.
Z-1962-2013
Product summary
- Firm
- Remel Inc
- Event
- Event 64711
- Status
- Terminated
- Classification
- Class III
- Quantity
- 96 kits of 20 swab sets
- Official record key
device-enforcement:Z-1962-2013
Official wording
Reason: Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
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.
Derived failure modes
-
Unknown
Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.