Z-0383-2014Class III

MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222...

Name: Z-0383-2014 MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222...
Creator: Thermofisher Scientive
Published: 2013-10-29
License: https://open.fda.gov/license/

Thermofisher Scientive / initiated 2013-10-29 / Terminated

FDA source

Thermofisher Scientive began a recall of MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by... on 2013-10-29. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0383-2014
Classification: Class III
Status: Terminated
Initiated: 2013-10-29
Posted: 2013-11-22
Terminated: 2014-03-17
Recalling firm: Thermofisher Scientive
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 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.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 914 units
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.
Product codes and lots: Lot Number: UA1514011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0383-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0383-2014	Class III	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-22

Product code JJW

K973451Class IMas Liquid Urinalysis Control Level 1, Level 2 and Level 3Medical Analysis Systems, Inc. / cleared 1997-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)