DRG International recalls two lots of Total Thyroxine ELISA tests that expired before their shelf life, potentially delaying thyroid diagnosis and using patient samples.
Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.
DRG International is recalling two specific lots of Total Thyroxine ELISA tests that expired before their shelf life. Using these expired tests could delay thyroid diagnosis and waste patient samples.
The recalled lots expired before their shelf life, causing failed controls in the test. This could lead to delayed thyroid diagnosis and unnecessary use of patient samples.
People who use the recalled lots of Total Thyroxine ELISA tests for thyroid diagnosis may be affected. Those with recent thyroid tests using the expired lots are at higher risk.
Check for lot numbers RN-60923 (expires 12/31/2021) or RN-60831 (expires 12/31/2021) on the Total Thyroxine ELISA tests.
Look for lot numbers RN-60923 or RN-60831 with expiration dates of 12/31/2021.
The recalled lots expired before their shelf life, causing failed controls that may delay thyroid diagnosis and use patient samples.
Check for lot numbers RN-60923 (expires 12/31/2021) or RN-60831 (expires 12/31/2021) on the Total Thyroxine ELISA tests.
The recall does not specify a remedy, so contact DRG International for guidance.
We’ve drafted a message you can send DRG International to request your refund or repair — edit it as you like.
Subject: Recall Z-0310-2022 — DRG International DRG International Hello, I own a DRG International that is covered by recall Z-0310-2022 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.
