CLASS III Device recall · Reported 4 Dec 2013 · FDA Enforcement Report
MAS Urinalysis Control Level 1, Multi-analyte control recalled
Thermofisher Scientive is recalling MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), distributed nationwide in the US. The recall was initiated on 29 Oct 2013 and the FDA has classified it as Class III.
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-0383-2014
- FDA event ID
- 66739
- Recalling firm
- Thermofisher Scientive, Fremont, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Oct 2013
- FDA classified
- 22 Nov 2013
- Reported
- 4 Dec 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Heart & Vascular Devices
Timeline
| 29 Oct 2013 | Recall initiated by company | |
| 22 Nov 2013 | Classified by FDA | +24 days |
| 4 Dec 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
Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011.
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
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
Where it was distributed
Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.
Questions about this recall
Is MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed) recalled?
Yes. Thermofisher Scientive recalled MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed) on 29 Oct 2013. The recall is Class III and its status is Terminated. Recall number Z-0383-2014.
Why was it recalled?
Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011.
Which lots are affected?
Lot Number: UA1514011
Where was it sold?
Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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