CLASS II ONGOING Device recall · Reported 6 Jul 2022 · FDA Enforcement Report

QMS Tacrolimus Immunoassay recalled by Microgenics

Microgenics is recalling QMS Tacrolimus Immunoassay, distributed in 21 states. The recall was initiated on 20 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/Part Number: 10015573 UDI Codes: (01) 0884883 01259 2 (17) 220310 (10) 74175462 (01) 0884883 01259 2 (17) 220512 (10) 74267412 Lot Numbers: 74175462 74267412 Calibrators within the 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 recalled615 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1284-2022
FDA event ID: 90225
Recalling firm: Microgenics, Fremont, CA
Classification: Class II
Status: Ongoing
Recall initiated: 20 Jan 2022
FDA classified: 24 Jun 2022
Reported: 6 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Test Kits & Diagnostics

Timeline

20 Jan 2022	Recall initiated by company
24 Jun 2022	Classified by FDA	+155 days
6 Jul 2022	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for 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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

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

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

Questions about this recall

Why was it 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.

Which lots are affected?

Model/Part Number: 10015573 UDI Codes: (01) 0884883 01259 2 (17) 220310 (10) 74175462 (01) 0884883 01259 2 (17) 220512 (10) 74267412 Lot Numbers: 74175462 74267412 Calibrators within the 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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Microgenics

All 11

Reported	Class	Recall	Company	Reason	Where
5 Nov 2025Device	CLASS II	In Vitro Diagnostic external control recalled by Microgenics	Microgenics	Potency & Assay	Nationwide
12 Oct 2016Device	CLASS II	Thermo Scientific QMS Everolimus Assay recalled by Microgenics	Microgenics	Potency & Assay	Nationwide
5 Oct 2016Device	CLASS II	DRI Salicylate Serum Tox Assay recalled by Microgenics	Microgenics	Potency & Assay	Nationwide
10 Dec 2014Device	CLASS II	MAS CardioImmune XL Cardiac Marker Control recalled by Microgenics	Microgenics	Potency & Assay	Nationwide
2 Jul 2014Device	CLASS III	MAS Omni Immune Controls recalled by Microgenics	Microgenics	Packaging Defects	Nationwide

Other Test Kits & Diagnostics recalls

All 2,663

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Device	CLASS II	DxC 500 AU Clinical Chemistry Analyzers: AU w/out ISE recalled	Beckman Coulter	Device Malfunction	Nationwide
14 Oct 2026Device	CLASS II	DxC 500i Clinical Analyzer Modules: DxC 500 AU Module w/ISE recalled	Beckman Coulter	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	McKesson Consult hCG Urine Cassette recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide
7 Oct 2026Device	CLASS II	Systems/units containing affected recalled	Beckman Coulter Mishima K.K	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Fisher Scientific Sure-Vue Urine hCG recalled by Alere San Diego	Alere San Diego	Potency & Assay	Nationwide