Recall Z-1563-2013 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Microgenics Corporation
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 liste
| Date | Jun 21, 2013 (initiated May 13, 2013) |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 188 |
| Distribution | Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031890 | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL Medical Analysis Systems, Inc., Jul 16, 2003 |