CLASS II Device recall · Reported 3 Jul 2013 · FDA Enforcement Report
Thermo Scientific MAS Bilirubin for Siemens recalled by Microgenics
Microgenics is recalling Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, Product is, distributed nationwide in the US. The recall was initiated on 13 May 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1563-2013
- FDA event ID
- 65187
- Recalling firm
- Microgenics, Fremont, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2013
- FDA classified
- 21 Jun 2013
- Reported
- 3 Jul 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Heart & Vascular Devices
Timeline
| 13 May 2013 | Recall initiated by company | |
| 21 Jun 2013 | Classified by FDA | +39 days |
| 3 Jul 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.
Nationwide ArizonaColoradoFloridaIllinoisNew JerseyNew YorkPennsylvaniaUtahWisconsin
Questions about this recall
Why was it 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.
Which lots are affected?
Catalog Number: 10014432; Lot Numbers: 1MQ310, Expiration Date: 31 Dec 2013, 2CQ310, Expiration Date: 31 Mar 2014, 2KQ310, Expiration Date: 31 Oct 2014
Where was it sold?
Nationwide Distribution: US including the states of WI, UT, FL NY, PA, IL, CO, AZ and NJ.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Microgenics
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | In Vitro Diagnostic external control recalled by Microgenics | Microgenics | Potency & Assay | Nationwide |
| Device | CLASS II | QMS Tacrolimus Immunoassay recalled by Microgenics | Microgenics | Potency & Assay | 21 states |
| Device | CLASS II | Thermo Scientific QMS Everolimus Assay recalled by Microgenics | Microgenics | Potency & Assay | Nationwide |
| Device | CLASS II | DRI Salicylate Serum Tox Assay recalled by Microgenics | Microgenics | Potency & Assay | Nationwide |
| Device | CLASS II | MAS CardioImmune XL Cardiac Marker Control recalled by Microgenics | Microgenics | Potency & Assay | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |