FDASeptember 24, 2018device
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 variou...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
What to do
FDA enforcement status: Terminated
Brands named
roche diagnosticsroche
UPCs
03617556001
Recall history
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