DRG International recalls T4 Total ELISA kits (model EIA-4568) due to incorrect expiration dates on box labels, which could lead to inaccurate test results. Affected kits were sold between 2025-01-01 and 2025-03-31.
An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
DRG International is recalling T4 Total ELISA kits because the box labels show an expiration date two months past the actual shelf life of the test components. This could cause inaccurate test results if used after the correct expiration date.
The kit box labels show an expiration date of March 31, 2026, but the actual shelf life of the test components ends on January 31, 2026. Using the kit after January 31, 2026, could lead to inaccurate test results due to expired components.
Users of T4 Total ELISA kits with model EIA-4568 who purchased them between January 2025 and March 2025 are likely affected. Laboratory staff and researchers using these kits for testing are at the highest risk.
Check for the model number EIA-4568 on the kit box. Kits sold between January 2025 and March 2025 are affected. The box label shows an expiration date of March 31, 2026, but the actual shelf life ends January 31, 2026.
Verify the expiration date on the box label matches the actual shelf life of the test components (January 31, 2026).
The box labels show an expiration date two months past the actual shelf life of the test components, which could lead to inaccurate test results.
Yes, the bottle labels show the correct expiration date of January 31, 2026.
Check the expiration date on the box label against the actual shelf life (January 31, 2026). If it's past this date, stop using the kit.
We’ve drafted a message you can send DRG International to request your refund or repair — edit it as you like.
Subject: Recall Z-2265-2025 — DRG International DRG International Hello, I own a DRG International that is covered by recall Z-2265-2025 from DRG International. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
