Class II — Potential Health Hazard

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

EliA Sample Diluent Recalled by Phadia US Inc Due to Erroneous EliA test results related to problems with...

Date: January 30, 2017
Company: Phadia US 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 Phadia US Inc directly.

Affected Products

EliA Sample Diluent, Article number, 83-1023-01

Quantity: 5957

Why Was This Recalled?

Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.

Where Was This Sold?

This product was distributed to 27 states: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NH, NJ, NM, NY, NC, OH, OR, PA, SD, TN, TX, VA, WV, WI

Affected (27 states)Not affected

About Phadia US Inc

Phadia US Inc has 9 total recalls tracked by RecallDetector.

Related Recalls

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