Roche Recalls cobas p 501 Post-Analytical Units Due to Sharp Edges
Roche is recalling 9,014 cobas p 501 Post-Analytical Units because a sharp edge on the sample rack tray caused four reported injuries.
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 meets the rubric criteria for a Severe (4) rating.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 9,014 units of the cobas p 501 Post-Analytical Unit calculator/data processing module. The recall is due to a sharp edge on the center guide rail of the analyzer's sample rack tray, which has caused four reported injuries.
The affected product is used in the MODULAR PRE-ANALYTICS system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling. The units were distributed nationwide in the United States.
Roche has revised the cleaning procedure for the sample rack tray to clarify the cleaning process. Users of this equipment should stop using the affected units and contact Roche for further instructions.
The recalled product
- Product
- cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR
- 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