Z-0749-2020Class II

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

Name: Z-0749-2020 Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US -
Creator: Roche Diabetes Care, Inc.
Published: 2019-09-30
License: https://open.fda.gov/license/

Roche Diabetes Care, Inc. / initiated 2019-09-30 / Terminated / root cause: design

FDA source

Roche Diabetes Care, Inc. began a recall of Blood Glucose Monitoring System, Model Number 07400942001 ACCU-CHEK GUIDE METER ONLY MG/DL US - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring... on 2019-09-30. FDA classified it as Class II and gives the reason as "Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0749-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-30
Posted: 2019-12-30
Terminated: 2020-07-29
Recalling firm: Roche Diabetes Care, Inc.
Product: 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.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
Root cause tag: design
FDA root cause: Device Design
Action: On October 23, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail for the Accu-Chek Guide blood glucose meters with a serial number below 92311000001. The serial number can be found on the back of the meter, where indicated by the red rectangle in the photo below. It instructs them to: 1) Always have a spare set of batteries. The meter requires two (2) size CR2032 batteries. 2) Be aware that battery life may vary due to factors such as temperature and battery manufacturer. 3) Have a back-up testing method available. 4) If you have questions regarding this notification or you need further support, please contact our Accu-Chek Customer Care team through our website (accuchek.com), email address ([email protected]), or call (1-800-858-8072). 5) If there is a Business Reply Card enclosed with this mailing, please complete and return it as instructed on the Business Reply Card. 6) Keep a copy of this notification for your records. If you are currently experiencing a power issue with your Accu-Chek Guide meter, follow the instructions below. If the meter is powered on and displaying an E-9 error or low battery icon: a. Move the meter to a more moderate environment, such as ambient room temperature, to ensure optimal battery performance. b. Turn the meter off, then turn the meter back on. c. If the problem persists, perform a meter reset by doing the following: i) Remove the batteries. ii) Press and hold the Power/Set/OK button for at least 2 seconds. iii) Reinsert the batteries. d. If the problem still occurs after performing a meter reset, then replace the batteries with new ones according to the instructions in the user manual. Use high quality batteries in the meter, such as Panasonic. The meter requires two (2) size CR2032 batteries. e. If replacing the batteries does not correct the situation, please contact our Accu-Chek Customer Care team through our website (accu-chek.com), email address (accu-chek
Quantity in commerce: 21,094
Distribution: 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.
Product codes and lots: Model Number : 07400942001 Device Identifier: 00365702702066 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0749-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0747-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2019-12-30
Z-0748-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2019-12-30
Z-0749-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2019-12-30
Z-0750-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2019-12-30
Z-0751-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2019-12-30
Z-0752-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-08	2019-12-30

Product code NBW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)