Class II — Potential Health Hazard

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

Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two Recalled by Medtest Holdings, Inc. Due to Decrease reactivity of R 1 component.

Date: March 13, 2012
Company: Medtest Holdings, Inc.
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 Medtest Holdings, Inc. directly.

Affected Products

Pointe Scientific Hitachi Total Bilirubin Rl Reagent Product Usage: Two part Chemistry Reagent Hitachi Total Bilirubin Rl Reagent is used with Hitachi Total Bilirubin R2 Reagent for the quantitative determination of total bilirubin in serum on Hitachi analyzers. For in vitro diagnostic use only.

Quantity: 270.36 L

Why Was This Recalled?

Decrease reactivity of R 1 component.

Where Was This Sold?

This product was distributed to 10 states: CA, FL, GA, IL, MI, NY, OK, OR, TX, VA

Affected (10 states)Not affected

About Medtest Holdings, Inc.

Medtest Holdings, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

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