Reported Aug 21, 2013 · Terminated
Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control…
Remel Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Remel Inc · 12076 Santa Fe Trail Dr · Lenexa, KS · 66215-3519
Is this the product you have?
- 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.
- Lot codes and dates
Lot 260745exp. 5/31/2014
- Amount recalled
- 96 kits of 20 swab sets
Where it was sold
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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