FDA Devices recall · Reported December 4, 2013
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
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.
Thermofisher Scientive recalled MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Pa… - a low-severity action.
MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Pa… was recalled by Thermofisher Scientive in December 4, 2013. Reason: Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day o…. Check the official notice for the remedy. Verify recall #Z-0383-2014 with the FDA Devices before acting.
The recall
Thermofisher Scientive issued this low-severity FDA Devices recall-Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day o….
- Low
- severity level
- 914 units
- affected scope
- Class III
- classification
- December 4, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0383-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0383-2014 |
| Date reported | December 4, 2013 |
| Date initiated | October 29, 2013 |
| Recalling firm | Thermofisher Scientive |
| Firm location | Fremont, CA |
| Affected scope | 914 units |
| Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0383-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Low), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026