Recall Z-1563-2013— Microgenics Corporation

Name: FDA recall Z-1563-2013
Creator: U.S. Food and Drug Administration
Published: 2013-05-13

Class II · Terminated

Class II FDA medical device recall by Microgenics Corporation, initiated 2013-05-13, terminated 2013-08-27. It names one FDA 510(k) clearance: K031890. Product: Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.. Reason: It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability..

Recalling firm: Microgenics Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-05-13
Terminated: 2013-08-27
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K031890 — MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROLMedical Analysis Systems, Inc.·cleared 2003-07-16

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

Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS Bilirubin is intended for use as a consistent test sample of known concentration for monitoring assay conditions in many clinical laboratory determinations. Includes Bilirubin with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Reason for recall

It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability.

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