Device product
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
Z-1179-2017
Product summary
- Event
- Event 75936
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,571 packs/90 slides totalling 3,381,390 slides
- Official record key
device-enforcement:Z-1179-2017
Official wording
Reason: There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
Code information: Product Code REF 680 0120 Lot: GENs 14-18 Expiry Date range 01-JAN-2017 through 01-MAY-2018
Distribution pattern: Worldwide distribution - Nationwide U.S.A; International - Bermuda, Australia, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
Derived failure modes
-
Unknown
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.