Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic Recalled by Pointe Scientific, Inc. Due to Creatinine kit C7539-150 contains Creatinine reagent R1 that...

Date: December 12, 2014
Company: Pointe Scientific, 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 Pointe Scientific, Inc. directly.

Affected Products

Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.

Quantity: 93 kits

Why Was This Recalled?

Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Pointe Scientific, Inc.

Pointe Scientific, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

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