Recall Z-1284-2022— Microgenics Corporation

Name: FDA recall Z-1284-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-20

Class II · Ongoing

Class II FDA medical device recall by Microgenics Corporation, initiated 2022-01-20. It names one FDA 510(k) clearance: K123343. 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: 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..

Recalling firm: Microgenics Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-01-20
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K123343 — THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORSMicrogenics Corp.·cleared 2013-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.