Roche Modular Analytics Systems Recalled Due to Sharp Sample Rack Edge
Roche is recalling Modular Analytics Combination Systems because a sharp edge on the sample rack tray caused four reported injuries. The cleaning procedure has been revised to clarify the process.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves four reported injuries, which aligns with the rubric criteria for a Severe rating (Class II with injury reports).
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling Roche/Hitachi MODULAR Analytics Combination Systems, including the Modular D/P Clinical Chemistry Analyzer and Modular E170 Immunoassay Analyzer. The recall is due to a sharp edge on the center guide rail of the analyzer's sample rack tray.
The company received four reports of injury caused by this sharp edge. The cleaning procedure for the sample rack tray has been revised to clarify the cleaning process. The recall covers 9,014 units distributed nationwide in the United States.
Healthcare facilities using these systems should contact Roche Diagnostics Operations, Inc. for instructions on the revised cleaning procedure and any necessary corrective actions.
The recalled product
- Product
- Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clin
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 9,014
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)
- Not applicable
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Roche Diagnostics Operations, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
Same manufacturer · Roche Diagnostics Operations, Inc.
See all →- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11
- HighThyroid receptor immunoassay recalled over variable results across instrument platforms
FDA (Devices) · 2026-01-14
- HighMedical Device Homocysteine Test Assay Recalled for Calibration Defects
FDA (Devices) · 2024-11-27
- HighRoche Creatine Kinase test reagents recalled for calibration errors
FDA (Devices) · 2024-10-02
- HighRoche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
FDA (Devices) · 2023-11-29
Same hazard · sharp edge
See all →- HighOBP Medical Recalls Vaginal Speculums Due to Potential Sharp Edges
FDA (Devices) · 2026-08-19
- HighMRI Machine Coil Seal Adhesive May Create Sharp Edges
FDA (Devices) · 2024-02-07
- SevereMedline Nursing Skills Kit: Tracheostomy Brush Sharp Edge and Bristle Defect
FDA (Devices) · 2024-01-03
- SevereMedline Nurse Training Kits Recalled for Sharp Tracheostomy Brush
FDA (Devices) · 2024-01-03
- SevereMedline Tracheostomy Care Kits Recalled for Sharp Brush and Bristle Detachment
FDA (Devices) · 2024-01-03