Class 2 Device Recall Roche Diagnostics URISYS 1100 Urine Analyzer

• Date Initiated by Firm: September 24, 2018
• Create Date: October 31, 2018
• Recall Status: Terminated on February 09, 2022
• Recall Number: Z-0301-2019
• Recall Event ID: 81177
• 510(K)Number: K033548
• Product Classification: Reagent, occult blood - Product Code KHE
• Product: 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, bilirubin and blood
• Code Information: All serial numbers
• Recalling Firm/ Manufacturer: Roche Diagnostics Corporation; 9115 Hague Rd; Indianapolis IN 46256-1025
• For Additional Information Contact: Roche Customer Support Center; 800-428-2336
• Manufacturer Reason for Recall: 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
• FDA Determined 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: ¿ You can choose to read the test strips visually or ¿ If you continue to use the strips with the Urisys 1100 urine analyzer, a negative result for any of the four affected parameters (protein, nitrite, leukocytes, and erythrocytes) must be repeated with a new test strip that is read visually. Follow the directions in the instructions for Manually Reading Chemstrip Test Strip Results section of the UMDC. 3. If you are unable to implement the visual read-only method for Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, or Chemstrip 10 UA test strips: ¿ Dispose of the affected test strip vials per local guidelines. ¿ Contact your distributor partner for credit. 4. Complete all sections of the enclosed fax back forms Contact Roche Diagnostics Point-of-Care Technical Service, 24 hours a day, seven days a week at 1-800-428-4674 if you have questions
• Quantity in Commerce: 14,398 units
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KHE and Original Applicant = ROCHE DIAGNOSTICS CORP.