Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista… — Class II medical device recall Z-1563-2013
Terminated recall by Microgenics Corporation, reported 2013-07-03, distributed nationwide. It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed i
| Recall number | Z-1563-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microgenics Corporation, Fremont, CA, United States |
| Recall initiated | 2013-05-13 |
| Classified | 2013-06-21 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2013-08-27 |
| Distributed | Nationwide (US) |
| Quantity | 188 |
| Reason classes | specification failure |
| Lot numbers | 1MQ310, 2CQ310, 2KQ310 |
| Model numbers | 10014432 |
| Expiration dates | 2013-12-31, 2014-03-31, 2014-10-31 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1563-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.