Agency classClass IIOur severity:High FDA (Devices)·Z-0168-2014·Announced 2013-11-13

Roche COBAS INTEGRA 800 Analyzer Recalled for Software Maintenance Defect

Roche Diagnostics is recalling 527 COBAS INTEGRA 800 Analyzers with software version 9864.C2 because the system fails to perform necessary ISE service actions and maintenance requests.

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: The recall involves a high-risk medical device where a software defect prevents necessary maintenance actions, posing a risk of harm to patients through potential diagnostic errors, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 527 units of the COBAS INTEGRA 800 Analyzer equipped with software version 9864.C2. The affected units correspond to COBAS Part Numbers 28122474001, 28122474692, 04559126001, and 04589459970, which include the analyzer with or without the closed tube sampling accessory. These devices are fully automated systems intended for in vitro quantitative and qualitative clinical chemistry analysis of body fluids.

The recall was initiated because the software does not perform necessary ISE (Ion-Selective Electrode) Service Actions. Specifically, whenever the ISE rack is removed, the ISE counters in the software are reset to zero, and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that must be performed manually by the operator are not requested on the software interface.

The affected products were distributed nationwide and in Puerto Rico. Healthcare facilities and laboratories using these analyzers should contact Roche Diagnostics Operations, Inc. for instructions on how to resolve the software defect.

The recalled product

Product: COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for…
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — Clinical Chemistry Analyzer
Hazard: software-defect
maintenance-failure
Affected units: 527

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)

software version 9864.C2

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Roche Diagnostics Operations, Inc.

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