Remel recalls specific lots of Thio Med w/Dex, Hemin, and Vit K (5ml) 20/PK due to shortened expiration dates from 7 months to 56 days after manufacturing, risking product failure in testing.
Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
Remel is recalling specific lots of Thio Med w/Dex, Hemin, and Vit K (5ml) 20/PK because the expiration date is shortened to 56 days after manufacturing instead of 7 months. This could cause the product to fail performance testing during use in qualitative procedures.
The product's expiration date is shortened to 56 days after manufacturing instead of 7 months. This means the product may fail performance testing during use in qualitative procedures, but it does not pose a direct health risk.
Users of these specific lots of Thio Med w/Dex, Hemin, and Vit K (5ml) 20/PK for laboratory cultivation. Lab technicians and researchers using the product are most at risk.
Check for lot numbers: 328725 (01/16/2019), 345633 (02/20/2019), 346706 (02/27/2019), 385229 (05/07/2019), 396646 (05/30/2019), or 399823 (06/11/2019).
Verify the expiration date on the product label matches the shortened 56-day period from manufacturing.
The product's expiration date is shortened to 56 days after manufacturing instead of 7 months, which could cause it to fail performance testing in qualitative procedures.
Lots 328725 (01/16/2019), 345633 (02/20/2019), 346706 (02/27/2019), 385229 (05/07/2019), 396646 (05/30/2019), and 399823 (06/11/2019).
No, but you should check the expiration date to ensure it hasn't expired before the 56-day period.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-1378-2019 — Remel Remel Hello, I own a Remel that is covered by recall Z-1378-2019 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.
