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U.S. Department of Health and Human Services

Class 2 Device Recall Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems

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 Class 2 Device Recall Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systemssee related information
Date Initiated by FirmMay 13, 2013
Date PostedJune 21, 2013
Recall Status1 Terminated 3 on August 27, 2013
Recall NumberZ-1563-2013
Recall Event ID 65187
510(K)NumberK031890 
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
ProductThermo 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.
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 
FEI Number 3010939897
Recalling Firm/
Manufacturer		 Microgenics Corporation
44660 Osgood Rd
Fremont CA 94539-6410
For Additional Information ContactLaurie Wong
510-979-5000 Ext. 5145
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionThermoFisher 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 Commerce188
DistributionNationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = JJX
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