CLASS II Device recall · Reported 7 Nov 2018 · FDA Enforcement Report
Urisys 1100 Urine Analyzer recalled by Roche Diagnostics
Roche Diagnostics is recalling Roche Diagnostics Urisys 1100 Urine Analyzer, distributed nationwide in the US. The recall was initiated on 24 Sep 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0301-2019
- FDA event ID
- 81177
- Recalling firm
- Roche Diagnostics, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Sep 2018
- FDA classified
- 31 Oct 2018
- Reported
- 7 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 24 Sep 2018 | Recall initiated by company | |
| 31 Oct 2018 | Classified by FDA | +37 days |
| 7 Nov 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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
Where it was distributed
US Nationwide Distribution
Questions about this recall
Is Urisys 1100 Urine Analyzer recalled?
Yes. Roche Diagnostics recalled Urisys 1100 Urine Analyzer on 24 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0301-2019.
Why was it recalled?
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
Which lots are affected?
All serial numbers
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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