Severity
Low
LowClass IIITerminated
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
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 FDA Devices action (record #Z-0383-2014) was formally reported on December 4, 2013, with the manufacturer initiating the action on October 29, 2013. It is classified under Low severity (Class III), with a current status of Terminated. Thermofisher Scientive is listed as the recalling firm, operating out of Fremont, CA. Federal records list the affected scope as 914 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
914 units
Related Recalls
6
3 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Thermofisher Scientive. Units affected: 914 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2013. Severity: Low. Recall number: Z-0383-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0383-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 4, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.