Remel Thioglycollate Medium Recalled for Performance Testing Failures
Remel Inc is recalling specific lots of Thioglycollate Medium because the products intermittently failed performance testing during stability studies.
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, and the hazard involves performance testing failures without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Remel Inc is voluntarily recalling 384 units of Remel Thioglycollate Medium W/O Indicator W/ Dextrose. The affected products include 9ml vials (Ref 064700 and 064702) and 10ml vials (Ref 07176) with specific lot numbers listed in the recall notice. 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 intended use in laboratory settings.
Healthcare facilities and laboratories should stop using the affected lots immediately. Users should check their inventory for the specific reference numbers and lot numbers identified in the recall and contact Remel Inc for instructions on returning or disposing of the product.
The recalled product
- Product
- remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 384
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 (9)
- (a) 9ML
- REF 064700
- Lot numbers: 254751
- 259508
- 272498 (b) 10ML
- REF 07176
- Lot numbers: 259521 (c) 9ML
- REF 064702
- Lot numbers: 274247
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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