Z-1563-2013 Class II Terminated
FDA device recall Z-1563-2013 was initiated by Microgenics Corporation on May 13, 2013 and is designated Class II. 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. The recall status is terminated (terminated August 27, 2013). Affected quantity: 188.
Recall Details
- Product Type
- Devices
- Report Date
- July 3, 2013
- Initiation Date
- May 13, 2013
- Termination Date
- August 27, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 188
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.
Distribution Pattern
Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.
Code Information
Catalog Number: 10014432; Lot Numbers: 1MQ310, Expiration Date: 31 Dec 2013, 2CQ310, Expiration Date: 31 Mar 2014, 2KQ310, Expiration Date: 31 Oct 2014