Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A Control Swa

FDA device recall Z-1962-2013 · posted 2013-08-13 · Terminated

Recall details

Recalling firm

Remel Inc

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.

Action taken

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).

Root cause

Employee error

Status

Terminated

Product code

GNX

Quantity affected

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.

Date initiated

2013-02-19

Date posted

2013-08-13

Date terminated

2013-08-14

Location

Lenexa, KS