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TAUNS SARS coronavirus antigen kit: ImmunoAce SARS-CoV-2 III - Recall
Official notice
28 May 2026
Last checked
27 Oct 2026
An official CAA Japan notice concerns TAUNS SARS coronavirus antigen kit: ImmunoAce SARS-CoV-2 III - Recall. A faint test line appearing with line-shaped areas of white discoloration may suggest a false positive. Reason for recall: Multiple medical institutions reported quality issues involving specific lots, including suspected false positives due to faint test lines appearing with line-shaped areas of white discoloration. Investigation confirmed white discoloration around the antibody immobilization site in the test plate's result area [T], with a relatively faint black line appearing at the antibody immobilization site. The affected lots are therefore being voluntarily recalled. Specific potential health effects: Use of the affected lots may produce false-positive results, so an impact on safety and effectiveness cannot be ruled out. However, SARS-CoV-2 infection is diagnosed through a comprehensive assessment of other test results and clinical symptoms, rather than this product's test result alone. We therefore consider serious adverse health effects unlikely. No adverse health effects associated with this issue have been reported to date. Published 2026-05-28.
What to do now
All delivery recipients have been identified. Our representatives will provide information and conduct the voluntary recall.
Units affected
3,000
Recall number
2-12819
Official notice
2026-05-28
The hazard
The hazard
A faint test line appearing with line-shaped areas of white discoloration may suggest a false positive. Reason for recall: Multiple medical institutions reported quality issues involving specific lots, including suspected false positives due to faint test lines appearing with line-shaped areas of white discoloration. Investigation confirmed white discoloration around the antibody immobilization site in the test plate's result area [T], with a relatively faint black line appearing at the antibody immobilization site. The affected lots are therefore being voluntarily recalled. Specific potential health effects: Use of the affected lots may produce false-positive results, so an impact on safety and effectiveness cannot be ruled out. However, SARS-CoV-2 infection is diagnosed through a comprehensive assessment of other test results and clinical symptoms, rather than this product's test result alone. We therefore consider serious adverse health effects unlikely. No adverse health effects associated with this issue have been reported to date.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Check the official notice for the affected products and next steps.
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Where it was sold
Where it was sold
Retailer information is not currently available in RecallScope. Check the official notice for distribution details.
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Company & contacts
Company & contacts
Brand
Manufacturer
Phone
Brand: タウンズ. Contact: 株式会社タウンズ 品質本部 薬事・品質保証部. Phone 0558-77-2255.
Source & status
Source & status
Recall details
Recall details
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Documents, notices & source
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