Remel recalls Thio Med w/o Ind w/Dex (10ml) 20/PK due to shortened expiration dates causing potential failure in performance testing after 106 days.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.
Remel is recalling Thio Med w/o Ind w/Dex (10ml) 20/PK products because they may fail performance testing after 106 days instead of the standard 9 months. This could lead to unreliable results in lab tests if used beyond the shortened expiration.
The product's expiration date is shortened from 9 months to 105 days due to potential failure in performance testing starting at 106 days after manufacturing. This means the product may not work correctly in lab tests if used beyond the shortened expiration.
Laboratory users who purchased Thio Med w/o Ind w/Dex (10ml) 20/PK from Remel. Those using the product for qualitative procedures in microbiology labs are most at risk.
Check for lot numbers: 307916 (12/11/2018), 337081 (01/31/2019), 359857 (03/19/2019), 381201 (04/30/2019) or 423518 (07/30/2019) for the first batch, and 311677 (12/18/2018) through 417781 (07/17/2019) for the second batch.
Verify the product's expiration date against the lot numbers listed in the recall notice.
The product may fail performance testing after 106 days from manufacturing, shortening the expiration date from 9 months to 105 days.
Check for lot numbers: 307916 (12/11/2018), 337081 (01/31/2019), 359857 (03/19/2019), 381201 (04/30/2019) or 423518 (07/30/2019) for the first batch, and 311677 (12/18/2018) through 417781 (07/17/2019) for the second batch.
The recall does not require immediate action beyond checking the expiration date against the listed lot numbers.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-1404-2019 — Remel Remel Hello, I own a Remel that is covered by recall Z-1404-2019 from Remel. 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.
