Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 Recalled by Instrumentation Laboratory Co. Due to HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned)...

Date: November 15, 2013
Company: Instrumentation Laboratory Co.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Instrumentation Laboratory Co. directly.

Affected Products

HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120

Quantity: 80319 Kits

Why Was This Recalled?

HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Instrumentation Laboratory Co.

Instrumentation Laboratory Co. has 31 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report