FDA-Device2022-07-06Class II
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
Microgenics Corporation
Hazard
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.
Sold states
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
Affected count
615 kits
Manufactured in
46500 Kato Rd, Fremont, CA, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1284-2022Don't want to check this manually?
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