HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 00... (Instrumentation Laboratory Co.) – hemosil low, abnormal, normal control... (2013)
Class II: 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 recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Brand
Instrumentation Laboratory Co.
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Instrumentation Laboratory Co. is recalling HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 due to HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Mar 8, 2026