Class II — Potential Health Hazard

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

Access Hybritech p2PSA reagent Recalled by Beckman Coulter, Inc. Due to Reagent lot numbers include an insufficient concentration of...

Date: May 17, 2023
Company: Beckman Coulter, Inc.
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 Beckman Coulter, Inc. directly.

Affected Products

Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

Quantity: 987 kits

Why Was This Recalled?

Reagent lot numbers include an insufficient concentration of blocking reagent.

Where Was This Sold?

This product was distributed to 19 states: CA, CO, CT, FL, GA, IL, IN, MA, MI, NE, NJ, NY, NC, OH, SC, TN, TX, UT, WA

Affected (19 states)Not affected

About Beckman Coulter, Inc.

Beckman Coulter, Inc. has 79 total recalls tracked by RecallDetector.

Related Recalls

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