| Class 3 Device Recall Remel Xpect Flu A&B Control Swabs | |
Date Initiated by Firm | February 19, 2013 |
Date Posted | August 13, 2013 |
Recall Status1 |
Terminated 3 on August 14, 2013 |
Recall Number | Z-1962-2013 |
Recall Event ID |
64711 |
Product Classification |
Antigens, cf (including cf control), influenza virus a, b, c - Product Code GNX
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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. |
Code Information |
Lot 260745, exp. 5/31/2014 |
Recalling Firm/ Manufacturer |
Remel Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
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For Additional Information Contact | Earleen C. Parks 913-895-4185 |
Manufacturer 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. |
FDA Determined Cause 2 | 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 1-877-428-1924.
If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International). |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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