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FDA-Device2026-03-11Class IIPROCESSING DEFECT

Roche cobas pro analyzer recalled for software defect causing incorrect lab results

Roche Diagnostics
OTHERNationwide distribution

Contact Roche about cobas pro analyzer software issue

Roche Diagnostics' cobas pro automated laboratory analyzer has a software defect that can cause it to accept incorrect calibrations. When this happens, the machine repeats the same result for multiple patient and quality-control tests instead of calculating new values, potentially leading to inaccurate lab results. This affects specific blood tests including ferritin, vancomycin, and light chain measurements.

  • If your laboratory operates a cobas pro system, contact Roche Diagnostics immediately
  • Do not use affected assays until you receive guidance from Roche
  • Update your system software to version 03-02 or later
  • Review recent test results from affected assays with Roche's help
Hazard

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.

Sold states
US Nationwide distribution.
Affected count
1261 total
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1476-2026

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