FDA recall Z-1284-2022

Microgenics Corporation · Class II · device

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

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.

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

Key facts

Status: Ongoing
Initiation date: 2022-01-20
Report date: 2022-07-06
Voluntary/Mandated: Voluntary: Firm initiated
Location: Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1284-2022