Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0383-2014 · Posted 2013-11-22

Recalling FirmThermofisher Scientive
Recall StatusTerminated
Product CodeJJW
Date Initiated2013-10-29
Date Terminated2014-03-17
Product Quantity914 units

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.

Firm Action

ThermoFisher Scientific, sent an Urgent Medical Device Field Correction letter dated October 29, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use, segregate and discard the affected product. Customers with questions were instructed to contact [email protected]. For question regarding this recall call 1-800-232-3342.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973451MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3Medical Analysis Systems, Inc. · 1997-09-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑