Quick Facts at a Glance
- Recall Date
- January 20, 2026
- Hazard Level
- HIGH
- Brand
- Roche Diagnostics Operations
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Roche Diagnostics Operations
- Product type
- Automated Clinical Chemistry and Immunochemistry Analyzer
- Model numbers
- cobas pro sample supply unit, cobas pro SSU, UDI-DI 07613336158852 cobas pro SSU, UDI-DI 07613336179499 all software versions previous to 03-02
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 20, 2026
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Roche Diagnostics Operations, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The cobas pro integrated solutions system, including cobas c 503 units, is an automated analyzer used in clinical laboratories to run qualitative, semi-quantitative and quantitative chemistry and immunochemistry assays.
Why This Is Dangerous
A software fault can cause the system to repeat the last valid result for spline-type assays. This can produce identical, incorrect patient and QC results, potentially affecting patient care.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Labs may produce inaccurate results. This can affect diagnosis and treatment plans and may require retesting and clinical review.
Practical Guidance
How to identify if yours is affected
- Identify if your lab has cobas pro integrated solutions with cobas c 503 units.
- Check for model numbers: cobas pro sample supply unit and cobas pro SSU; material numbers 08464502001 and 09205632001.
- Confirm affected assays: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein(a) Gen.2, Lipoprotein(a) molarity, Vancomycin Gen.3, KFLCX, LFLC, FCAL turbo.
- Review the recall letter for facility-specific instructions and action timelines.
Where to find product info
Recall letter from Roche Diagnostics Operations, FDA enforcement page, and Roche’s official recall notices.
What timeline to expect
Timeline for resolution not provided by the manufacturer. Follow recall instructions for updates.
If the manufacturer is unresponsive
- Escalate to hospital risk management or compliance office.
- File a formal request with Roche and monitor for escalation pathways provided in the recall notice.
How to prevent similar issues
- Keep software up to date and apply vendor-issued calibration patches promptly.
- Implement lab-wide calibration verification procedures before resuming affected assays.
- Establish a recall monitoring process for laboratory equipment and devices.
- Verify any future calibration methods and spline-type dependencies with the vendor.
Documentation advice
Preserve the recall letter, maintain a log of communications with the manufacturer, and document any test results affected by the defect.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Product: cobas pro integrated solutions with cobas c 503 analytical units. Cobas pro sample supply unit material number 08464502001. Cobas pro SSU material number 09205632001. Assays affected include Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen.2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel. Distribution: US Nationwide. Quantity: 1261 total units. Recall date: 2026-01-20. Manufacturer: Roche Diagnostics Operations.
Key Facts
- Assays affected: Cystatin C Gen.2; Ferritin Gen.4; Lp(a) Gen.2; Lp(a) molarity; Vancomycin Gen.3; KF
- LCX; LFLC; FCAL turbo
- Class II recall
- US nationwide distribution
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
