Instrumentation Laboratory Recalls HemosIL Normal Control Kits Lacking Approval
Instrumentation Laboratory is recalling 8,0319 kits of HemosIL Normal Control 1 UNASSAYED because the product lacks FDA 510(k) approval.
What this means for you
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. The hazard is a regulatory compliance issue (lack of 510(k) approval) rather than a direct physical injury or contamination, fitting the criteria for a moderate severity voluntary or regulatory recall.
Plain-English summary
Instrumentation Laboratory Co. is recalling 8,0319 kits of HemosIL Normal Control 1 UNASSAYED, Part Number 0020003120. The recall covers all lots of the product, which was distributed nationwide.
The recall was initiated because the product lacks FDA 510(k) approval. The source text identifies the product as 'HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned)'.
Consumers and healthcare facilities should stop using the affected control kits and contact Instrumentation Laboratory for further instructions.
The recalled product
- Product
- HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
- Manufacturer
- Instrumentation Laboratory Co.
- Affected units
- 80,319
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.
See all 3 products in this recall →Related recalls
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