FDA Medical Device Recalls (openFDA)
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, bilirubin and blood
- Recall number
- Z-0301-2019
- Recalling firm
- Roche Diagnostics Corporation
- 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
- Status
- Terminated
- Initiated
- 2018-09-24
- Posted
- not on file
- Terminated
- 2022-02-09
- 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: 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
- 14,398 units
- Distribution
- US Nationwide Distribution
- Lot, serial or model codes
- All serial numbers
- 510(k) numbers
- ["K033548"]
- PMA numbers
- not on file
- Product code
- KHE
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28