Remel Thio Med w/Dex, Hem, Vit, K Media Recalled for Performance Failure
Remel Inc is recalling Thio Med w/Dex, Hem, Vit, K media because it may fail performance testing after 57 days. The expiration date is shortened to 56 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 where the use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. No injuries or illnesses are reported in the source text.
Plain-English summary
Remel Inc is recalling 242 units of Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK. This product is a general purpose media recommended for use in qualitative procedures 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 57 days after the date of manufacturing. As a result, the expiration date is shortened from 7 months to 56 days.
The affected lots are 309152 (10/10/2018), 337708 (12/03/2018), 353574 (01/02/2019), and 378524 (02/20/2019). The products were distributed nationwide in the United States and internationally to Singapore.
The recalled product
- Product
- Thio Med w/Dex, Hem, Vit, K (7ml) 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
- 242
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)
- Lot Number (Expiration Date): 309152 (10/10/2018)
- 337708 (12/03/2018)
- 353574 (01/02/2019)
- 378524 (02/20/2019).
Distribution
Part of a larger recall action
This product is one of 4 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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