Recall Z-0301-2019 ยท KHE Reagent, Occult Blood
Roche Diagnostics Corporation
Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine test strips for various urine analytes.: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen,
| Date | Sep 24, 2018 |
| Status | Terminated |
| Reason | Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the Urisys 1100 urine analyzer with Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA test strips were higher than what is listed in the test strip method sheets may lead to false negative results for the affected parameters |
| Root cause | Under Investigation by firm |
| Action | Roche Diagnostics notified Consignees by the Urgent Medical Device Correction (UMDC) sent UPS Ground (receipt required) on 9/24/18. For consignees associated only with a PO number address, the UMDC will be sent by USPS mail. Consignee Instructions: 1. When using Chemstrip 5 Ob and/or Chemstrip 7 test strips, results should only be read visually. These test strips can no longer be read on the Urisys 1100 urine analyzer. Follow the directions in the Instructions for Manually Reading Chemstrip test Strip results section of the UMDC. 2. When using Chemistrip 10 MD or Chemstrip 10 UA test strips: |
| Quantity | 14,398 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033548 | ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER Roche Diagnostics Corp., Nov 24, 2003 |