Remel Thioglycollate Medium Recalled for Performance Testing Failures
Remel Inc is recalling Remel Thioglycollate Medium (Ref 05152) because products intermittently failed performance testing during stability studies.
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 involves a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text describes performance failures without reporting specific injuries or illnesses, fitting the Moderate severity criteria for a precautionary recall of a medical device.
Plain-English summary
Remel Inc is recalling Remel Thioglycollate Medium, Reference 05152. The recall involves 48 units from Lot 258192. These products were distributed in the United States, Canada, and Singapore.
The recall was initiated because the products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. This indicates that the medium may not perform as intended for its specific laboratory use.
Users of this product should stop using the affected units and contact Remel Inc for further instructions or a replacement.
The recalled product
- Product
- remel THIOGLYCOLLATE MEDIUM, REF 05152
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 48
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 (1)
- Lot number: 258192
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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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