Instrumentation Laboratory Recalls Unapproved HemosIL High Abnormal Control 3 Kits
Instrumentation Laboratory is recalling 84,561 kits of HemosIL High Abnormal Control 3 UNASSAYED because the product lacks FDA 510(k) approval.
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. The hazard is regulatory (lack of approval) rather than a direct physical safety defect with reported harm, fitting the 'Moderate' criteria for low-risk or voluntary/precautionary contexts where no harm is documented.
Plain-English summary
Instrumentation Laboratory Co. is recalling 84,561 kits of HemosIL High Abnormal Control 3 UNASSAYED (Part Number: 0020003320). The recall covers all lots of this product, which was distributed nationwide.
The recall was initiated because the product lacks FDA 510(k) approval. The source text identifies the product as 'UNASSAYED (no-value assigned),' indicating it is a control material intended for laboratory use rather than a finished diagnostic test with established reference values.
Consumers and laboratories should stop using the affected product and contact the manufacturer for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
- Manufacturer
- Instrumentation Laboratory Co.
- Affected units
- 84,561
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)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Instrumentation Laboratory Co. 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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