Z-0301-2019Class II

Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001

Name: Z-0301-2019 Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001
Creator: Roche Diagnostics Corporation
Published: 2018-09-24
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2018-09-24 / Terminated

FDA source

Roche Diagnostics Corporation began a recall of Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to... on 2018-09-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0301-2019
Classification: Class II
Status: Terminated
Initiated: 2018-09-24
Posted: 2018-10-31
Terminated: 2022-02-09
Recalling firm: Roche Diagnostics GmbH
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
Product code: KHE Reagent, Occult Blood
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 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 in commerce: 14,398 units
Distribution: US Nationwide Distribution
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0301-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0301-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-10-31

Product code KHE

K033548Class IIRoche Diagnostics Urisys 1100 Urine AnalyzerRoche Diagnostics Corp. / cleared 2003-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)