Severity
Low
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.
Reported: August 21, 2013 Initiated: February 19, 2013 #Z-1962-2013 96 kits of 20 swab sets units
Remel Inc issued this FDA Devices recall on August 21, 2013. Classified as Low severity (Class III). Approximately 96 kits of 20 swab sets units are affected. The recall was issued because: Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-1962-2013) was formally reported on August 21, 2013, with the manufacturer initiating the action on February 19, 2013. It is classified under Low severity (Class III), with a current status of Terminated. Remel Inc is listed as the recalling firm, operating out of Lenexa, KS. Federal records indicate 96 kits of 20 swab sets units are affected.
The documented reason for this recall is: Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit. Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
96 kits of 20 swab sets
Related Recalls
6
6 from same agency
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.
Details
- Recalling Firm
- Remel Inc
- Units 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.
- Location
- Lenexa, KS
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1962-2013 |
| Date reported | August 21, 2013 |
| Date initiated | February 19, 2013 |
| Recalling firm | Remel Inc |
| Units 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Remel Inc. Units affected: 96 kits of 20 swab sets.
Why was this product recalled? ▼
Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2013. Severity: Low. Recall number: Z-1962-2013.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1962-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).