Remel recalls Thio Med w/Dex, Hem, Vit K (10ml) 100/pack due to potential failure in performance testing after 106 days from manufacturing, reducing expiration from 9 months to 105 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/Dex, Hem, Vit K (10ml) 100/pack because these products may fail performance testing after 106 days from manufacturing. This means the expiration date is shortened from 9 months to 105 days, which could lead to unreliable test results if used beyond this period.
The products may fail performance testing after 106 days from manufacturing. This shortens the expiration date from 9 months to 105 days, meaning the product could become unreliable if used beyond this timeframe.
Users of Thio Med w/Dex, Hem, Vit K (10ml) 100/pack for qualitative procedures in labs or medical settings. Those who have the product with lot numbers listed in the recall are most at risk.
Check for lot numbers: 314206 (12/20/2018), 315673 (12/25/2018), 322659 (01/07/2019), and other dates listed in the recall. The product is used for qualitative procedures in labs or medical settings.
Look for the lot number on the product label to see if it matches the listed numbers: 314206 (12/20/2018), 315673 (12/25/2018), 322659 (01/07/2019), etc.
The products may fail performance testing after 106 days from manufacturing, shortening the expiration date from 9 months to 105 days.
Check the product lot number to see if it matches the listed numbers. If it does, contact Remel for guidance.
The recall does not provide a remedy; users should check the lot number and contact Remel if they have the affected product.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-1407-2019 — Remel Remel Hello, I own a Remel that is covered by recall Z-1407-2019 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.
