Z-1563-2013Class II

Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and...

Name: Z-1563-2013 Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and...
Creator: Microgenics Corporation
Published: 2013-05-13
License: https://open.fda.gov/license/

Microgenics Corporation / initiated 2013-05-13 / Terminated

FDA source

Microgenics Corporation began a recall of Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA MAS... on 2013-05-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1563-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-13
Posted: 2013-06-21
Terminated: 2013-08-27
Recalling firm: Microgenics Corporation
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.
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
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.
FDA root cause: Under Investigation by firm
Action: ThermoFisher Scientific sent a Product Recall Notification letter dated May 13, 2013, by Certified US mail to all affected customer. The letter identified the product the problem and the action needed to be taken by the customers. Customers were instructed 1. Determine if you are using or have inventory of the recalled product. 2. Discontinue use of the product immediately. 3. Evaluate quality controls. They may vary among laboratories and should be evaluated according to laboratory procedures. 4. Retain a copy of the letter for laboratory records. 5. If any of the affected lots of MAS Bilirubin had been forwarded to another laboratory, please provide a copy of the recall letter to them. 6. Complete and return the response form within 5 days. Letters also provide an alternative product - MAS Bilirubin part number BC103. Questions or concerns may be directed to Technical Services at 1-800-232-3342 or 510-979-5417.
Quantity in commerce: 188
Distribution: Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.
Product codes and lots: Catalog Number: 10014432; Lot Numbers: 1MQ310, Expiration Date: 31 Dec 2013, 2CQ310, Expiration Date: 31 Mar 2014, 2KQ310, Expiration Date: 31 Oct 2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1563-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1563-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-21

Product code JJX

K031890Class IMas Bilirubin Liquid Assayed Bilirubin ControlMedical Analysis Systems, Inc. / cleared 2003-07-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)