Remel Thio Med Culture Media Recalled for Potential Performance Failure
Remel Inc is recalling Thio Med culture media due to potential performance failures after 106 days. The expiration date is shortened to 105 days.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity. The hazard involves potential performance failure of a diagnostic medium rather than direct physical injury or death.
Plain-English summary
Remel Inc is recalling 76 units of Thio Med w/o Ind, w/Dex (18ml) 100/PK culture media. The product is recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes.
The recall is due to the potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after the date of manufacturing. Consequently, the expiration date is shortened from 9 months to 105 days.
The affected lots include Material Number R08856 with Lot Numbers 314864, 343867, 367396, and 387017, as well as Expansion Lot Number 423518. The products were distributed nationwide in the United States and internationally to Canada. Users should stop using the affected products and contact Remel Inc for further instructions.
The recalled product
- Product
- Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 76
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Material Number: R08856
- Lot Number (Labeled Expiration Date): 314864 (12/24/2018)
- 343867 (02/14/2019)
- 367396 (04/02/2019)
Distribution
Part of a larger recall action
This product is one of 10 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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