Recall Z-1962-2013— Remel Inc
Class III · Terminated
Class III FDA medical device recall by Remel Inc, initiated 2013-02-19, terminated 2013-08-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit..
- Recalling firm
- Remel Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-02-19
- Terminated
- 2013-08-14
- Firm location
- Lenexa, KS, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.