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ACCU-CHEK GUIDE recallZ-0747-2020 · Roche Diabetes Care, Inc. · initiated Sep 30, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Roche Diabetes Care, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Device Design

What the company is doing

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

Recall details

Recall number
Z-0747-2020
Status
Terminated
Initiated by the company
Sep 30, 2019
Posted by the FDA
Dec 30, 2019
Recalling firm
Roche Diabetes Care, Inc.
Quantity
318,678
Product code
NBW
FDA submissions
K160944
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 description

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.

Code information (models, lots, serial numbers)

Model Number : 07400870001 Device Identifier: 00365702702035 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

13 devices cleared under K160944 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 84119).

Sources and updates

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