Acumedia Recalls Palcam Supplement Due to Possible Bacillus Contamination
Acumedia Manufacturers, Inc. is recalling Palcam Supplement (PN 7987) due to possible contamination with Bacillus spp. The product is used for Listeria enrichment.
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 hazard is a 'possible' contamination with Bacillus spp. in a laboratory reagent, which fits the criteria for a voluntary precautionary recall or low-risk contamination without reported illness.
Plain-English summary
Acumedia Manufacturers, Inc. is recalling 28 units of Palcam Supplement, Product Number 7987, Lot 108044. The recall is being conducted because the product is contaminated with possible Bacillus spp.
Palcam Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. from foods, dairy, and environmental samples. The affected units were distributed worldwide, including in the United States (specifically in Wisconsin, New Jersey, and New York) and in Brazil, Ecuador, Singapore, and Canada.
Consumers and laboratories should stop using the affected product and contact Acumedia Manufacturers, Inc. for further instructions or a refund.
The recalled product
- Product
- Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.
- Manufacturer
- Acumedia Manufacturers, Inc.
- Hazard
- Affected units
- 28
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 (2)
- PN 7987
- Lot 108044
Distribution
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