Lower risk Medical device recall · FDA · Published January 20, 2022

Microgenics QMS Tacrolimus Calibrators May Cause Over-Quantitation in Patient Results

Microgenics recalls QMS Tacrolimus calibrators that may over-quantitate tacrolimus patient results, leading to inaccurate medication levels. Affected units include specific model numbers and lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1284-2022Medical device Microgenics ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmMicrogenics Corporation46500 Kato Rd · Fremont, CA 94538-7310

✎ GovInfoNow plain-language explainer

Microgenics is recalling QMS Tacrolimus calibrator sets that can cause over-quantitation in patient tacrolimus test results. This means the test might show higher medication levels than actual, risking incorrect dosing decisions. Read more at govinfonow.com/recall/61245-microgenics-qms-tacrolimus-calibrators-may-cause-over-quantitation-in-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/61245-microgenics-qms-tacrolimus-calibrators-may-cause-over-quantitation-in-patient · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1284-2022

Cite this page

“Microgenics QMS Tacrolimus Calibrators May Cause Over-Quantitation in Patient Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61245-microgenics-qms-tacrolimus-calibrators-may-cause-over-quantitation-in-patient. Based on FDA recall #Z-1284-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1284-2022%22&limit=1).

The FDA announced on Jan. 20, 2022, that Microgenics Corporation is recalling QMS Tacrolimus Immunoassay calibrator sets due to inaccurate recovery values. The defect may result in over-quantitation of tacrolimus patient results. Owners should contact the company for a refund.

How to tell if you have it

Brand: Microgenics
Product: QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET
Components: 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
Model/Part Number: 10015573
Lot Numbers: 74175462, 74267412
Quantity: 615 kits

The hazard

According to the FDA, the QMS Tacrolimus Calibrators recovered between 82 to 94% of their target values. This defect results in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay.

Context

GovInfoNow's records show Microgenics Corporation has one other recall on record since Oct. 1, 2025, involving Thermo Scientific MAS Omni CARDIO Recall: Vial Variability Risk in Troponin I Assays on that date. Other recent recalls of similar products include Siemens Dimension Tacrolimus Flex Reagent Cartridge Recall (May 7, 2026), Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026), and Fujirebio Lumipulse G Amyloid 1-42 Plasma Calibrators Recall (Dec. 11, 2025).

How to tell if you have this one

Check for the model numbers 10015566-3 through 10015571-3 on the calibrators. Affected units have lot numbers 74175462 or 74267412 and UDI codes starting with (01) 0884883 01259 2.

Brand
Microgenics
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Calibrator Model Numbers
Look for model numbers 10015566-3 through 10015571-3 on the calibrators.

Where it went and when

Where it was distributed

Distributed in 20 states and D.C., and outside the U.S.

FDA distribution: “U.S.: AL, AZ, CA, DC, FL, IA, ID, IL, KY, LA, MA, NE, NJ, NM, OH, OK, PA, SC, TN, TX, and VA O.U.S.: Bangladesh, Brazil, Canada, Germany, India, Malaysia, Mexico, South Korea, and Thailand” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, District of Columbia, Florida, Idaho, Illinois, Iowa, Kentucky, Louisiana, Massachusetts, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia.

Recall timeline

FDA published this recall 5 months after the firm started it.

Jan 20, 2022Firm started the recall
Jun 24, 2022FDA classified it Class II
Jul 6, 2022Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/61245-microgenics-qms-tacrolimus-calibrators-may-cause-over-quantitation-in-patient">Microgenics QMS Tacrolimus Calibrators May Cause Over-Quantitation in Patient Results (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1284-2022 (January 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1284-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.