AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Reported: June 17, 2015 Initiated: April 22, 2015 #Z-1733-2015
Product Description
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Reason for Recall
Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnoticed may lead to severe hyperglycemia u
Details
- Recalling Firm
- Roche Diabetes Care, Inc.
- Units Affected
- 35,795
- Distribution
- Nationwide Distribution
- Location
- Indianapolis, IN
Frequently Asked Questions
What product was recalled? ▼
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.. Recalled by Roche Diabetes Care, Inc.. Units affected: 35,795.
Why was this product recalled? ▼
Roche has become aware of an increase of mechanical errors experienced by customers using the Accu-Chek Spirit Combo insulin infusion pump and Accu-Chek Spirit insulin infusion pump when the insulin pumps display E6 and El0 error messages. If the user does not act upon the E6 and E10 error messages appropriately, insulin delivery will be stopped and if unnoticed may lead to severe hyperglycemia u
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2015. Severity: Moderate. Recall number: Z-1733-2015.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11