Remel Flu A&B Control Swabs Recalled for Incorrect Quality Control Results
Remel Inc is recalling Flu A&B Control Swabs because they may provide incorrect negative results for Flu A, potentially compromising quality control testing.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a functional defect in a quality control material rather than a direct safety risk to patients.
Plain-English summary
Remel Inc is recalling Remel X/pect Flu A&B Control Swabs, Reference R246003, Lot 260745, with an expiration date of 5/31/2014. The product consists of 96 kits, each containing 20 Flu A Control Swabs and 20 Flu B Control Swabs, individually packaged in foil pouches. The swabs are intended for in vitro diagnostic use as external quality control material for the Remel Xpect Flu A&B test kit.
The recall was initiated because the Flu A+ Control Swabs may incorrectly yield Flu A- results when used for quality control testing with the Xpect Flu A&B test kit. This defect could lead to inaccurate quality control assessments for the diagnostic test.
The affected product was distributed nationwide in the following states: AL, AR, CA, CO, CT, FL, GA, IA, IL, KS, MA, MD, MI, MO, NM, NV, NY, OH, PA, TX, WA, and WI. Users of this product should stop using the affected swabs and contact Remel Inc for further instructions or a replacement.
The recalled product
- 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…
- Manufacturer
- Remel Inc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 260745
- exp. 5/31/2014
Distribution
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