The Recall Desk
LowFDA (Devices)·Z-0383-2014·Announced 2013-12-04

Thermo Fisher Recalls MAS Urinalysis Control Level 1 for Stability Failure

Thermo Fisher Scientific is recalling 914 units of MAS Urinalysis Control Level 1 because the product failed to meet 30-day open vial stability specifications.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a failure to meet stability specifications, a documentation and quality control issue rather than a direct safety hazard like contamination or injury.

Plain-English summary

Thermo Fisher Scientific is recalling 914 units of MAS Urinalysis Control Level 1, a multi-analyte control material used in clinical laboratories for routine urinalysis testing. The affected product is identified by Lot Number UA1514011 and Catalog Number 024222. The recall was initiated after a consumer complaint and in-house testing confirmed that the product does not meet the required 30-day open vial stability specifications.

The product was distributed worldwide, including nationwide in the United States (including Puerto Rico) and internationally to Hong Kong. The MAS Urinalysis Control Level 1 is intended for use as a control for qualitative and semi-quantitative procedures to assure consistent performance of reagents and equipment in physiochemical, chemical, and microscopic methods of routine urinalysis.

Users should stop using the affected lot and contact Thermo Fisher Scientific for further instructions or a replacement.

The recalled product

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 i
Manufacturer
Thermofisher Scientive
Category
Medical Device — Laboratory Control Material
Hazard
Affected units
914

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: UA1514011

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same hazard · stability failure

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