MAS Urinalysis Control Level 1 — Class III medical device recall Z-0383-2014
Terminated recall by Thermofisher Scientive, reported 2013-12-04, distributed nationwide. Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day op
| Recall number | Z-0383-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thermofisher Scientive, Fremont, CA, United States |
| Recall initiated | 2013-10-29 |
| Classified | 2013-11-22 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2014-03-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | HK |
| Quantity | 914 units |
| Reason classes | specification failure |
| Lot numbers | UA1514011 |
| Model numbers | 024222 |
Product
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.
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-0383-2014. 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.