Class II — Potential Health Hazard

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

ANTI-BORRELIA (LYME) MICROPLATE EIA Kit Recalled by Innominata Dba Genbio Due to Multiple incidents of low-reacting assay plates.

Date: February 11, 2013
Company: Innominata Dba Genbio
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 Innominata Dba Genbio directly.

Affected Products

ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.

Quantity: 195

Why Was This Recalled?

Multiple incidents of low-reacting assay plates.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Innominata Dba Genbio

Innominata Dba Genbio has 1 total recall tracked by RecallDetector.

Related Recalls

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