Class II — Potential Health Hazard

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

BIOCARE Medical Recalled by Biocare Medical, LLC Due to Their is a potential that the automated staining...

Date: February 25, 2021
Company: Biocare Medical, LLC
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 Biocare Medical, LLC directly.

Affected Products

BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1

Quantity: 72 units

Why Was This Recalled?

Their is a potential that the automated staining instrument with software version 3.5.3.1 may move with random speeds in random direction across its range of motion. This could result in the instrument hitting end stops or running into other components on the working deck. This could also result in wash buffer being dispensed on random locations.

Where Was This Sold?

This product was distributed to 15 states: AL, AZ, CA, CT, FL, IL, MD, MA, MN, NC, OH, OR, PA, WA, WY

Affected (15 states)Not affected

About Biocare Medical, LLC

Biocare Medical, LLC has 9 total recalls tracked by RecallDetector.

Related Recalls

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