Roche Diabetes Care, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0752-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Blood Glucose Monitoring System, Model Number 08313202001 ACCU CHEK GUIDE HCP SAMPLE LAUNCH BOX - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring the effectiveness of glucose control. The Accu-Chek Guide blood Glucose Monitoring System is intended for in vitro diagnostic single-patient use by people with diabetes. The Accu-Chek Guide Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

Product Classification:

Class II

Date Initiated: September 30, 2019

Date Posted: January 8, 2020

Recall Number: Z-0752-2020

Event ID: 84119

Reason for Recall:

Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System.

Status: Terminated

Product Quantity: 452,392

Code Information:

Model Number : 08313202001 Device Identifier: 00365702702349 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).

Distribution Pattern:

US Nationwide distribution and countries of AR, AT, AU, BE, BR, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LT, LU, MM, MY, NL, NO, PH, PK, PT, SE, SG, TH, TW, ZA.

Voluntary or Mandated:

Voluntary: Firm initiated