Roche Diagnostics Recalls URISYS 1100 Urine Analyzers Due to Detection Limits
Roche Diagnostics is recalling 14,398 URISYS 1100 Urine Analyzers because limits of detection for certain parameters were higher than listed, potentially causing false negative results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect (higher limits of detection) may lead to false negative results, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Corporation is recalling 14,398 units of the URISYS 1100 Urine Analyzer (Part Number: 03617556001). The device 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. The recall covers all serial numbers and involves US nationwide distribution.
The recall was initiated because the Limits of Detection (LoD) for protein, nitrite, leukocytes, and erythrocytes on the analyzer were higher than what is listed in the test strip method sheets. This discrepancy may lead to false negative results for the affected parameters.
Healthcare facilities and laboratories using the URISYS 1100 Urine Analyzer should contact Roche Diagnostics Corporation for instructions on how to return the affected units or obtain a replacement.
The recalled product
- 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…
- Manufacturer
- Roche Diagnostics Corporation
- Category
- Medical Device — Urine Analyzer
- Affected units
- 14,398
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
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