Agency classClass IIOur severity:High FDA (Devices)·Z-0146-2015·Announced 2014-11-05

Roche Recalls ACCU-CHEK Spirit Combo Insulin Pumps Due to Time Settings

Roche is recalling 8,116 ACCU-CHEK Spirit Combo insulin pumps because a faulty capacitor may cause time and date settings to reset, potentially shifting insulin delivery schedules.

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 is classified as FDA Class II. The hazard involves a risk of harm (incorrect insulin delivery timing) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Roche Diagnostics Operations, Inc. is recalling 8,116 units of the ACCU-CHEK Spirit Combo insulin infusion pump, sold as part of the Accu-Chek Combo System. The recall affects specific model and catalog numbers, including the US/English and US/Spanish versions of the Combo Kit, as well as replacement and demo pumps.

The recall is due to a faulty capacitor that may cause the pump to lose its time and date settings during a power interruption, such as a battery change. If the capacitor fails, the time and date will return to the default setting. Although the pump prompts users to confirm the time and date, if a user does not recognize that the settings have reset, a shift in their basal rate time block could occur.

The affected products were distributed nationwide in the United States across 49 states, including California, New York, Texas, and Florida. Consumers with these devices should stop using them and contact Roche Diagnostics for further instructions.

The recalled product

Product: ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for screening or diagnosis of diabetes or for multiple patient use. It is indicated…
Manufacturer: Roche Diagnostics Operations, Inc.
Category: Medical Device — Insulin Pump
Hazard: device-malfunction
incorrect-dosing
Affected units: 8,116

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 (5)

Model/Catalog/Part Number: Accu-Chek Combo Kit mg US/English version
05458544001 Accu-Chek Combo Kit mg US/Spanish version
055004686001 Accu-Chek Spirit Combo Replacement Pump US/EN
05391512001 Accu-Chek Spirit Combo Demo Pump- US
0539175000

Distribution

Distributed nationwide across the United States.

The notice also names 48 states specifically:

Same manufacturer · Roche Diagnostics Operations, Inc.

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