Recall Z-0301-2019

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 taken

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