Z-0146-2015Class II

ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System

Name: Z-0146-2015 ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System
Creator: Roche Diagnostics Operations, Inc.
Published: 2014-09-25
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2014-09-25 / Terminated / root cause: manufacturing process

FDA source

Roche Diagnostics Operations, Inc. began a recall of 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... on 2014-09-25. FDA classified it as Class II and gives the reason as "The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0146-2015
Classification: Class II
Status: Terminated
Initiated: 2014-09-25
Posted: 2014-10-29
Terminated: 2018-01-10
Recalling firm: Roche Diagnostics GmbH
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 for the treatment of insulin requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger. The ACCU-CHEK Spirit Combo Insulin Pump is intended for the subcutaneous continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin as prescribed by a physician.
Product code: LZG Pump, Infusion, Insulin
Reason for recall: The insulin pump may lose time and date settings during a power interruption (such as a battery change) due to a faulty capacitor. If the capacitor fails, the time and date will return to default setting. Though the pump prompts customers to confirm the time and date, if the user does not recognize the time and date have returned to default, a shift of their basal rate time block could occur.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Roche sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated September 25, 2014 via UPS Ground (receipt required) to the consignees. The letter included a description of the reason for recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. No product returns were expected. For questions, contact the ACCU-CHEK Customer Care Service Center at 1-800-688-4578.
Quantity in commerce: 8116
Distribution: US Nationwide Distribution in the states of CA, CT, IA, NV, OH, IN, WI, GA, MO, NY, VA, LA, ME, TX, NC, ND, SD, NJ, CO, AL, SC, IL, KY, FL, OR, MN, MD, MS, AR, WV, WA, TN, CT, ID, KS, MI, PA, UT, MA, RI, NM, OK, DE, AZ, NE, MT, NV, WY, AK, and NH.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0146-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0146-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-05	2014-10-28

Product code LZG

K111353Class IIAccu-Check Combo SystemRoche Diagnostics / cleared 2012-07-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)