Z-1284-2022Class II

QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B...

Name: Z-1284-2022 QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B...
Creator: Microgenics Corporation
Published: 2022-01-20
License: https://open.fda.gov/license/

Microgenics Corporation / initiated 2022-01-20 / Open, Classified / root cause: manufacturing process

FDA source

Microgenics Corporation began a recall of 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... on 2022-01-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1284-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-01-20
Posted: 2022-06-24
Recalling firm: Microgenics Corporation
Product: 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
Product code: MLM Enzyme Immunoassay, Tracrolimus
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 01/20/2022, the firm contact via email its international customers regarding that the QMS Tacrolimus Calibrator was recovering between 82 to 94% of its target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay. On 03/10/2022, the firm notified its U.S. customer of the issue. Customers were instructed to: 1)Determine if they are using or have inventory of QMS Tacrolimus Calibrator catalog number 10015573, lot 74175462 or lot 74267412. 2)Discontinue use of affected in-date lots, and transition to new lot(s) where corrections have been made. Lot 74395275 and Lot 74459127 have had the testing correction applied and are currently available in stock to replace any of their remaining inventory of lots 74175462 or 74267412. 3)Dispose of the effected lots in accordance with local, regional, national regulations. 4)Contact your health care professional, as appropriate, for further action. " This notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected calibrator lots have been transferred. " Tacrolimus results reported with these affected calibrator lots do not need to be reanalyzed. " Retain a copy of this letter for your laboratory records. " Call Technical Service if assistance is needed for lot replacement (free of charge). " Please complete the Acknowledgment & Receipt Form attached to this Notification within 5 days of the date of this letter to Thermo fisher Scientific Technical Service. For questions, contact: -FAX: 888-527-8001 (USA only) or +1-510-979-5420 (outside USA) -PHONE: (+1)-800-232-3342 then press option 2, then option 2, or contact your local country representative. -E-mail: [email protected]
Quantity in commerce: 615 kits
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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1284-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1284-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-07-06	2022-06-24

Product code MLM

K123343Class IIThermo Scientific Qms Tacrolimus Assay and CalibratorsMicrogenics Corp. / cleared 2013-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)