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U.S. Department of Health and Human Services

Class 2 Device Recall QMS Tacrolimus Calibrator

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 Class 2 Device Recall QMS Tacrolimus Calibratorsee related information
Date Initiated by FirmJanuary 20, 2022
Create DateJune 24, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1284-2022
Recall Event ID 90225
510(K)NumberK123343 
Product Classification Enzyme immunoassay, tracrolimus - Product Code MLM
ProductQMS 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
Code Information 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
Recalling Firm/
Manufacturer		 Microgenics Corporation
46500 Kato Rd
Fremont CA 94538-7310
For Additional Information ContactMark Brandes
510-979-5000
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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: TechService.mgc@thermofisher.com
Quantity in Commerce615 kits
DistributionU.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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MLM
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