Class II — Potential Health Hazard

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

Streptex* Latex D Recalled by Remel Inc Due to The product may give weak or false negative...

Date: May 2, 2013
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

Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci

Quantity: 109 kits

Why Was This Recalled?

The product may give weak or false negative test results.

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