Remel Thio Med Culture Media Recalled for Potential Performance Failure
Remel Inc is recalling Thio Med culture media due to potential failure to meet performance standards after 106 days from manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text explicitly states no illnesses or injuries have been reported and the hazard is a theoretical performance failure, which limits the score to Moderate per the rubric.
Plain-English summary
Remel Inc is voluntarily recalling 736 units of Thio Med w/o Ind, w/Dex (9ml) 20/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 a potential for the 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 being shortened from 9 months to 105 days.
The affected product is identified by Material Number R064702. Specific lot numbers and their labeled expiration dates include 303274 (11/29/2018), 327634 (01/15/2019), 359077 (03/18/2019), 379729 (04/25/2019), 391553 (05/20/2019), and expansion lot 423547 (07/30/2019). The product was distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico, as well as internationally to Canada.
No illnesses or injuries have been reported in connection with this recall. Users should check their inventory for the specific material and lot numbers listed above and discontinue use of any units that have exceeded the revised 105-day expiration period from the date of manufacturing.
The recalled product
- Product
- Thio Med w/o Ind, w/Dex (9ml) 20/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
- 736
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 (5)
- Material Number: R064702
- Lot Number (Labeled Expiration Date): 303274 (11/29/2018)
- 327634 (01/15/2019)
- 359077 (03/18/2019)
- 379729 (04/25/2019)
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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