Class II — Potential Health Hazard

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

PathoDx Strep Grouping Kit Recalled by Remel Inc Due to A reagent present may produce weak or slow...

Date: June 30, 2015
Company: Remel 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 Remel Inc directly.

Affected Products

PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates.

Quantity: 1859 kits

Why Was This Recalled?

A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Remel Inc

Remel Inc has 70 total recalls tracked by RecallDetector.

Related Recalls

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