Remel Lyophilized Growth Supplement Recalled for Microbial Contamination
Remel Inc is recalling 10 units of a lyophilized growth supplement for Legionella testing due to potential low-level microbial contamination.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (incorrect diagnostic results) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Remel Inc is recalling 10 units of a lyophilized growth supplement used to prepare BCYE Medium for the isolation of Legionellae from clinical and environmental samples. The recall involves Lot 1175209.
The product is being recalled because it may contain low-level microbial contamination, which could result in incorrect test results. This is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences, or that the probability of serious adverse health consequences is remote.
Distribution was limited to the states of Illinois, Indiana, and Michigan. Users of the product should stop using it and contact Remel Inc for further instructions.
The recalled product
- Product
- The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
- Manufacturer
- Remel Inc
- Affected units
- 10
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 1175209
Distribution
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