Roche cobas analyzer may repeat previous results for spline calibrated assays
Roche is recalling cobas pro sample supply units on software versions before 03-02 because a defect can make the analyzer repeat the last calculated result for all later measurements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the analyzer can silently return stale results across eight assays, and no injuries are stated in the source.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling cobas pro integrated solutions with cobas c 503 analytical units, covering the cobas pro sample supply unit (material number 08464502001) and cobas pro SSU (09205632001). About 1,261 units were distributed nationwide in the United States. The FDA has classified this recall as Class II.
A software defect allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. 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 quality control results. Roche states the defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences.
Affected assays 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. All software versions previous to 03-02 are affected.
Laboratories can identify affected units by the material numbers and UDI-DIs 07613336158852 and 07613336179499, and may contact Roche Diagnostics Operations, Inc. for further information.
The recalled product
- 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 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1.…
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 1,261
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 (3)
- cobas pro sample supply unit
- UDI-DI 07613336158852 cobas pro SSU
- UDI-DI 07613336179499 all software versions previous to 03-02
Distribution
Distributed nationwide across the United States.
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