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 ReadiPlasTin Recalled by Instrumentation Laboratory Due to Variable and out of specification QC results with...

Date: April 8, 2022
Company: Instrumentation Laboratory
Status: Ongoing
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 directly.

Affected Products

HemosIL ReadiPlasTin, Part No. 0020301400

Quantity: 1,563 (US); 29,046 (OUS)

Why Was This Recalled?

Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Instrumentation Laboratory

Instrumentation Laboratory has 38 total recalls tracked by RecallDetector.

Related Recalls

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