Total Thyroxine ELISA Test Kits Recalled for Failed Quality Controls
DRG International is recalling Total Thyroxine (T4) ELISA test kits due to failed quality controls affecting 314 units across multiple countries. The defective controls may delay diagnosis and waste patient samples.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is loss of diagnostic utility due to failed quality controls and expired shelf life, a quality issue rather than immediate patient harm.
Plain-English summary
DRG International, Inc. is recalling Total Thyroxine (T4) ELISA test kits (REF EIA-1781) due to failed quality controls. The company identified two lots—RN-60923 and RN-60831—that do not meet the required shelf life specifications. A total of 314 units have been affected, distributed to the United States and internationally to countries including Tanzania, Vietnam, Bangladesh, Colombia, Trinidad and Tobago, Yemen, Bolivia, Germany, El Salvador, Georgia, Paraguay, Togo, Russia/Ukraine, Nicaragua, Dominican Republic, Nigeria, Egypt, and Cameroon.
When quality controls fail on a diagnostic test kit, the kits cannot provide reliable results. The clinical impact includes potential delay in diagnosis and consumption (waste) of patient blood samples that are used for testing. Healthcare facilities using these lots may not receive accurate thyroxine measurements, affecting patient care decisions.
If you have received this product, contact your healthcare provider or laboratory director for guidance. Units from lots RN-60923 and RN-60831 with expiration date 12/31/2021 should not be used and should be discarded or returned per manufacturer instructions.
The recalled product
- Product
- Total Thyroxine (T4) ELISA; REF EIA-1781
- Manufacturer
- DRG International, Inc.
- Hazard
- expired-shelf-life
- failed-controls
- diagnostic-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- lot#: RN-60923 expiration date 12/31/2021
- RN-60831 expiration date 12/31/2021
Distribution
Distributed in 3 states:
- CO
- DE
- NY
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