The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0515-2014·Announced 2013-12-25

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.

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 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.
Category
Medical Device — Laboratory Control
Hazard
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 →

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