Z-0146-2015 Class II Terminated
FDA device recall Z-0146-2015 was initiated by Roche Diagnostics Operations, Inc. on Sep 25, 2014 and is designated Class II. 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… The recall status is terminated (terminated Jan 10, 2018). Affected quantity: 8116.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 5, 2014
- Initiation Date
- Sep 25, 2014
- Termination Date
- Jan 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8116
Product Description
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.
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.
Distribution Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0146-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026