Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1284-2022 — 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

U.S. FDA — Device Enforcement · United States · 2022-01-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1284-2022
Date of alert
2022-01-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Microgenics Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10015573
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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