FDA Device recall Z-1179-2017
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine
- FDA Device
- Class II
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class II recall of VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine by Ortho Clinical Diagnostics, citing there is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1179-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-08 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Chemistry Products UPRO Slides, UPN 10758750000593, Product Usage: Quantitative measurement of total protein concentration in urine.
Reason
There is a potential for variable negatively and positively biased urine protein results using VITROS UPRO Slides.
Identifiers
| code_info | Product Code REF 680 0120 Lot: GENs 14-18 Expiry Date range 01-JAN-2017 through 01-MAY-2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1179-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.