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[Recalled] Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes — Potential for products to fail performance testing pe

recall fda device united-states

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

ProductThio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
Brand / manufacturerRemel Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1409-2019
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date17 April 2019

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Remel Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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