Agency classClass IIOur severity:High FDA (Devices)·Z-1077-2017·Announced 2017-02-01

Roche Recalls 30 Cobas b 123 POC Systems for Quality Control Issue

Roche Diagnostics is recalling 30 cobas b 123 POC systems because a software issue may prevent automatic quality control from running, potentially leading to undetected incorrect test results.

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 medical device where a software defect could lead to incorrect diagnostic results. While the source describes the risk as a 'remote possibility' and notes no reported injuries, the potential for undetected wrong results in a clinical setting fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 30 units of the cobas b 123 POC system, a fully automated point-of-care device used to measure blood gases, electrolytes, and other parameters. The recall affects specific models (cobas b 123 <2> and cobas b 123 <4>) and specific serial numbers listed in the agency record. The affected units were distributed nationwide, including in California, Louisiana, Nebraska, Puerto Rico, South Carolina, Texas, Virginia, and West Virginia.

The recall is due to a software issue that can occur when a Sensor Cartridge and a Fluid Pack are changed simultaneously. Under specific settings, the system may fail to perform the required follow-up automatic quality control (AutoQC) measurements after the Fluid Pack change. Without these quality control checks, there is a remote possibility that system issues would not be detected, and incorrect results for parameters such as pH, blood gases, electrolytes, and hemoglobin derivatives might not be excluded.

Healthcare facilities and users of the affected devices should stop using the recalled units and contact Roche Diagnostics for instructions on how to resolve the issue. The recall is voluntary and is being conducted to ensure patient safety by preventing the use of potentially inaccurate test results.

The recalled product

Product: Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb…
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — Point-of-Care Testing
Hazard: software-defect
incorrect-results
Affected units: 30

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Same manufacturer · Roche Diagnostics Operations, Inc.

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