Exact FDA event identifier

Event 84119

6 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 30, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Roche Diabetes Care, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - 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.

Z-0747-2020

Recall number: Z-0747-2020
Initiated: September 30, 2019
Classification: Class II
Status: Terminated
Recalling firm: Roche Diabetes Care, Inc.
Quantity: 318,678

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number : 07400870001 Device Identifier: 00365702702035 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.

device · product 2 of 6

Blood Glucose Monitoring System, Model Number 07400926001 ACCU-CHEK GUIDE RETAIL KIT MG/DL - 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.

Z-0748-2020

Recall number: Z-0748-2020
Initiated: September 30, 2019
Classification: Class II
Status: Terminated
Recalling firm: Roche Diabetes Care, Inc.
Quantity: 215,259

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number : 07400926001 Device Identifier: 00365702702042 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.

device · product 3 of 6

Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - 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.

Z-0749-2020

Recall number: Z-0749-2020
Initiated: September 30, 2019
Classification: Class II
Status: Terminated
Recalling firm: Roche Diabetes Care, Inc.
Quantity: 21,094

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number : 07400942001 Device Identifier: 00365702702066 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.

device · product 4 of 6

Blood Glucose Monitoring System, Model Number 08453071001 ACCU-CHEK GUIDE RETAIL KIT FCN MG/DL US - 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.

Z-0750-2020

Recall number: Z-0750-2020
Initiated: September 30, 2019
Classification: Class II
Status: Terminated
Recalling firm: Roche Diabetes Care, Inc.
Quantity: 3,996

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number : 08453071001 Device Identifier: 00365702729100 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.

device · product 5 of 6

Blood Glucose Monitoring System, Model Number 08453063001 ACCU-CHEK GUIDE SAMPLE KIT FCN MG/DL US - 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.

Z-0751-2020

Recall number: Z-0751-2020
Initiated: September 30, 2019
Classification: Class II
Status: Terminated
Recalling firm: Roche Diabetes Care, Inc.
Quantity: 355,400

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model Number : 08453063001 Device Identifier: 00365702728103 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.

device · product 6 of 6

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.

Z-0752-2020

Recall number: Z-0752-2020
Initiated: September 30, 2019
Classification: Class II
Status: Terminated
Recalling firm: Roche Diabetes Care, Inc.
Quantity: 452,392

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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.