Remel recalls Thio Med w/Dex, Hem, Vit K (5ml) 100/PK products with shortened expiry dates due to potential failure in performance testing after 57 days.
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 Thio Med w/Dex, Hem, Vit K (5ml) 100/PK products that may fail performance testing after 57 days. This affects products with specific lot numbers and shortened expiration dates from 7 months to 56 days.
These products may fail performance testing after 57 days from manufacturing. The expiration date is shortened from 7 months to 56 days to prevent this issue. This means the products could not work correctly in qualitative procedures after the shortened period.
Users of Thio Med w/Dex, Hem, Vit K (5ml) 100/PK for lab or medical purposes are affected. Lab technicians and researchers using these products are most at risk due to potential testing failures.
Check for lot numbers listed in the recall: 298222 (11/22/2018), 298278 (11/26/2018), and other specific dates. The product is used for growing bacteria in labs and medical testing.
Look for the lot number on the product label to see if it matches the listed numbers in the recall.
The expiration date is shortened from 7 months to 56 days to prevent potential failure in performance testing after 57 days.
The product may not work correctly in qualitative procedures for growing bacteria or testing, which could affect lab results.
Check the lot number on the product label against the list of specific lot numbers provided in the recall notice.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-1377-2019 — Remel Remel Hello, I own a Remel that is covered by recall Z-1377-2019 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.
