Class II — Potential Health Hazard

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

QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL Recalled by Microgenics Corporation Due to Due to QMS Tacrolimus Calibrator recovering between 82...

Date: January 20, 2022
Company: Microgenics Corporation
Status: Ongoing
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 Microgenics Corporation directly.

Affected Products

QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B 10015567-3 QMS TACROLIMUS CAL C 10015568-3 QMS TACROLIMUS CAL D 10015569-3 QMS TACROLIMUS CAL E 10015570-3 QMS TACROLIMUS CAL F 10015571-3

Quantity: 615 kits

Why Was This Recalled?

Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.

Where Was This Sold?

This product was distributed to 21 states: AL, AZ, CA, FL, ID, IL, IA, KY, LA, MA, NE, NJ, NM, OH, OK, PA, SC, TN, TX, VA, DC

Affected (21 states)Not affected

About Microgenics Corporation

Microgenics Corporation has 9 total recalls tracked by RecallDetector.

Related Recalls

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