Roche Diabetes Care, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1734-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

AccuChek Spirit insulin infusion pump.

Product Classification:

Class II

Date Initiated: April 22, 2015

Date Posted: June 17, 2015

Recall Number: Z-1734-2015

Event ID: 71235

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

Status: Terminated

Product Quantity: 35,795

Code Information:

All Serial Numbers Models: 1. 05458544001, Accu-Chek Combo Kit mg US/English version. 2. 05504686001, Accu-Chek Combo Kit mg US/Spanish version. 3. 05391512001, Accu-Chek Spirit Combo Replacement Pump US/EN. 4. 05391750001, Accu-Chek Spirit Combo Demo Pump US. 5. 04759702001, Accu-Chek Spirit Pump Kit US/CA Back Up. 6. 04540492001, Accu-Chek Spirit Pump Kit US/CA. 7. 04759729001, Accu-Chek Spirit Replacement Pump.

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated