DRG International, Inc. is recalling 47 units of the T4 Total ELISA test kits (Model EIA-4568) because of a labeling error. The expiration date on the outer kit box and the Certificate of Analysis is incorrectly listed as March 31, 2026, which exceeds the actual shelf life of the test components. The individual bottle labels inside the kit correctly show the expiration date as January 31, 2026. No incidents or injuries have been reported.
Using the test kit after its actual expiration date of January 31, 2026, may result in inaccurate medical test results because the standard and control solutions in the kit could degrade over time.
Expiration date on box and CoA incorrectly listed as 2026-03-31; correct shelf life ends 2026-01-31.
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Sources: FDA iRES · Raw API Response
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