Focus Diagnostics Recalls Anaplasma Phagocytophilum IFA IgM Test Kits
Focus Diagnostics is recalling 38 Anaplasma phagocytophilum IFA IgM Test Kits due to a potential increase in invalid results.
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 source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Focus Diagnostics Inc is recalling 38 units of the Anaplasma phagocytophilum IFA IgM Test Kit, Model No. IF1450M. The recall is being conducted because of the potential for an increase in invalid results.
The affected kits were distributed to non-US locations, specifically the Czech Republic, Denmark, Germany, Italy, Spain, and Colombia. The recall is associated with codes 26341 and 27011.
Consumers and healthcare providers who possess these specific kits should stop using them and contact Focus Diagnostics Inc for further instructions.
The recalled product
- Product
- Focus Diagnostics Anaplasma Phagocytophilum IFA IgM Test Kit, Model No. IF1450M in vitro diagnostic.
- Manufacturer
- Focus Diagnostics Inc
- Hazard
- Affected units
- 38
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)
- 26341
- 27011
Distribution
Distribution scope not specified by the agency.
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