Reported Jul 3, 2013 · Terminated
Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by…
Microgenics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Microgenics Corporation · 44660 Osgood Rd · Fremont, CA · 94539-6410
Is this the product you have?
- 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.
- Lot codes and dates
- Catalog Number10014432
- Lot Numbers1MQ310
- Expiration Date
31 Dec 20132CQ310
- Expiration Date
31 Mar 20142KQ310
- Expiration Date31 Oct 2014
- Amount recalled
- 188
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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