Z-1962-2013Class III

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

Name: Z-1962-2013 Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use, Ref R246003, each package contains 20 Flu A...
Creator: Remel Inc
Published: 2013-02-19
License: https://open.fda.gov/license/

Remel Inc / initiated 2013-02-19 / Terminated / root cause: manufacturing process

FDA source

Remel Inc began a recall of 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... on 2013-02-19. FDA classified it as Class III and gives the reason as "Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1962-2013
Classification: Class III
Status: Terminated
Initiated: 2013-02-19
Posted: 2013-08-13
Terminated: 2013-08-14
Recalling firm: Remel Inc
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.
Product code: GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
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.
Root cause tag: manufacturing process
FDA 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 1-877-428-1924. 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.
Product codes and lots: Lot 260745, exp. 5/31/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1962-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1962-2013	Class III	Terminated	Voluntary: Firm initiated	2013-08-21	2013-08-13

Product code GNX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)