Z-0383-2014 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2013
- Initiation Date
- October 29, 2013
- Termination Date
- March 17, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 914 units
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.
Code Information
Lot Number: UA1514011