Remel recalls Thio Med w/Dex, Hem, Vit K (10ml) 20/PK products with shortened expiration dates due to 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/Dex, Hem, Vit K (10ml) 20/PK products because they may fail performance testing after 106 days instead of the usual 9 months. This could lead to unreliable results in lab tests if used beyond the shortened expiration date.
The products may fail performance testing after 106 days from manufacturing, which is shorter than the standard 9-month expiration. This means lab tests could give incorrect results if used beyond the shortened expiration date.
Lab users who purchased Thio Med w/Dex, Hem, Vit K (10ml) 20/PK products with lot numbers listed in the recall. Those using the product for qualitative procedures are most at risk of inaccurate test results.
Check the lot number on the product label, which includes dates like 309155 (12/12/2018) through 398234 (06/06/2019). Products sold with these specific lot numbers are affected.
Verify the product's expiration date against the shortened 105-day period from manufacturing.
The products may fail performance testing after 106 days from manufacturing, so the expiration is shortened to 105 days to ensure reliability.
No, the recall does not require discarding the product. Users should check the expiration date against the shortened 105-day period.
Lot numbers 309155 (12/12/2018), 329971 (01/17/2019), 346674 (02/26/2019), 354842 (03/07/2019), 376323 (04/18/2019), 398234 (06/06/2019), and 404772 (06/13/2019) are affected.
We’ve drafted a message you can send Remel to request your refund or repair — edit it as you like.
Subject: Recall Z-1406-2019 — Remel Remel Hello, I own a Remel that is covered by recall Z-1406-2019 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.
