Roche Recalls Automated Analyzers Due to Possible Sample Mismatch
Roche Diagnostics is recalling 2,517 automated laboratory analyzers due to a software limitation that may cause sample mismatches.
What this means for you
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 risk-of-harm product (medical device) where a defect (sample mismatch) could lead to incorrect patient care, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Roche Diagnostics Corporation is recalling 2,517 units of the MODULAR Analytics E 170, cobas e 601, and cobas e 602 analyzers. These devices are fully automated, random-access, software-controlled systems used for immunoassay and photometric analysis in professional laboratory environments.
The recall is being conducted because a software limitation may cause a possible sample mismatch issue on the affected modules. This defect could lead to incorrect test results being associated with the wrong patient sample.
The affected units were distributed nationwide in the United States. Laboratory professionals should contact Roche Diagnostics for instructions on how to address the software limitation and ensure patient safety.
The recalled product
- Product
- Brand Name: ¿ cobas c 6000 MODULAR Series System e 601 ¿ cobas c 8000 MODULAR Series System - e 602 ¿ Roche / Hitachi MODULAR Analytics Combination System Model/Catalog/Part Number: MODULAR Analytics E 170 ¿ 03022109001 ¿ 03023109973 ¿ 03739040001 ¿ 03739040692 ¿ 05
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 2,517
Distribution
Distributed nationwide across the United States.
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