Recall Z-1962-2013 ยท GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Remel Inc
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 pr
| Date | Aug 13, 2013 (initiated Feb 19, 2013) |
| Status | Terminated |
| Reason | 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 | Employee error |
| Action | 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 1-877-42 |
| Quantity | 96 kits of 20 swab sets |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.