Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or tu
Check against the official notice below — it lists the full affected range.
Roche Diagnostics Operations, Inc. is recalling Roche COBAS INTEGRA c111 analyzers with catalog numbers 04777433001 and 04528778001 that have software versions up to and including 4.20. These in-vitro diagnostic instruments may encounter a software error that causes a measurement timing problem. Under rare conditions, if the instrument restarts a run, it may process two tests in the same cuvette. If a used cuvette is reused, the test results will be incorrect, and these erroneous results may not be flagged as errors. False high or low patient results could lead to incorrect diagnosis and treatment decisions, with the medical risk varying depending on the specific parameter being measured.
The recalled analyzers were distributed nationwide in the United States, with 139 units affected. The recall involves two catalog numbers: 04777433001 (COBAS c111 with ISE) and 04528778001 (COBAS c111 without ISE), both with software versions 4.20 or earlier. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter.
Reason for recall: cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20 may encounter the following alarm: 7002: 108000572, A software error occurred. This alarm is generated due to a measurement timing error. Under very rare conditions, the instrument may process two tests in the same cuvette if the run restarts. If a used cuvette is used again result of the test(s) will be erroneous. These erroneous results may not be flagged. Falsely low or high patient results may lead to incorrect diagnostic measures and medical therapeutic decisions. The medical risk depends on the parameter. Distribution: US Nationwide Distribution Quantity: 139 Lot/code info: 04777433001 Cobas c111 with ISE 04528778001 Cobas c111 without ISE cobas c 111 analyzers (catalog numbers 04777433001 and 04528778001) with software versions up to and including 4.20
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.