Instrumentation Laboratory Recalls HemosIL Low Abnormal Control 2 Kits
Instrumentation Laboratory is recalling 6,504 kits of HemosIL Low Abnormal Control 2 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, but the source text explicitly states the issue is a lack of 510(k) approval and does not report any illnesses or injuries. This aligns with the rubric for moderate severity involving regulatory or labeling issues without reported harm.
Plain-English summary
Instrumentation Laboratory Co. is recalling 6,504 kits of HemosIL Low Abnormal Control 2 UNASSAYED, Part Number 0020003220. 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 does not report any illnesses, injuries, or deaths associated with the use of these kits.
Users of these products should stop using them and contact Instrumentation Laboratory Co. for further instructions or a refund.
The recalled product
- Product
- HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
- Manufacturer
- Instrumentation Laboratory Co.
- Affected units
- 6,504
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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