Remel recalls Thio Med w/Dex, Hem, Vit K (9ml) 20/PK products with shortened expiration dates due to potential performance failures after 106 days of use.
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 (9ml) 20/PK products because they may fail performance testing after 106 days from manufacturing. This means the products expire earlier than the standard 9-month period, which could lead to unreliable results in lab tests.
The products may fail performance testing after 106 days from manufacturing, which shortens the expiration date from 9 months to 105 days. This could lead to unreliable results in lab tests if used beyond this timeframe.
Users of this lab culture medium, especially those in medical or research settings, may be affected. The risk is low as the issue relates to test accuracy rather than immediate safety.
Check the lot numbers on the product: 314201 (12/20/2018), 337680 (02/04/2019), 346705 (02/27/2019), 362709 (03/25/2019), 380471 (04/29/2019), or 396517 (05/28/2019).
Verify the product's expiration date against the lot number provided in the recall notice.
The products may fail performance testing after 106 days from manufacturing, shortening the expiration date from 9 months to 105 days.
Check the lot number on the product to see if it matches the listed numbers. If it does, the product may need to be used before the shortened expiration date.
No, the recall is for potential performance issues in lab tests, not a safety hazard.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-1403-2019 — Remel Remel Hello, I own a Remel that is covered by recall Z-1403-2019 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.
