FDAFDA · Food and drugs·Recall number Z-0383-2014
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.
Published December 4, 2013 · Recall initiated: October 29, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Thermofisher Scientive
- Distributor
- Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.
- Lot
- Lot Number: UA1514011
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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