Class III — Low Risk

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

LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Recalled by Alere San Diego, Inc. Due to Incorrect expiration date on the magnetic strip that...

Date: August 2, 2016
Company: Alere San Diego, 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 Alere San Diego, Inc. directly.

Affected Products

LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used to check the optics system of the LDX analyzer. Product Usage: The Optics Check Cassette is used to check the optics system of the Alere Cholestech LDX¿ Analyzer. It is run once a day before patient samples are tested and after the analyzer has been moved or serviced.

Quantity: 12,951

Why Was This Recalled?

Incorrect expiration date on the magnetic strip that does not match the labeled expiration date.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Alere San Diego, Inc.

Alere San Diego, Inc. has 49 total recalls tracked by RecallDetector.

Related Recalls

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