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ACCU-CHEK GUIDE recallZ-2174-2024 · Roche Diabetes Care, Inc. · initiated May 13, 2024

Open, Classified

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

The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may result in the wrong unit of measure. Which may subsequently cause an error in interpreting a result as approximately 18 times lower that the actual blood glucose. Potential immediate health consequences of the glucose meter providing a reading in the wrong units of measurement (UOM) may result in inappropriate rescue therapy for presumed hypoglycemia including urgent and repeat administration of carbohydrates. This in turn could lead to frequent episodes of hyperglycemia which is unrecognized and undertreated.Long range consequences of continued use of the affected meters could include mismanagement of the patient s diabetes for longer periods of time potentially resulting in a major health event (in general persistent and/or severe hyperglycemia) that may lead them to seek medical attention, and depending on the duration of hyperglycemia, could contribute to the development of microvascular (i.e., retinopathy, neuropathy, nephropathy) and/or macrovascular (i.e., myocardial infarction, ischemic stroke) complications of diabetes and could lead to fetal damage (abnormal fetal growth and altered organ development and maturation, fetal hypoxemia, spontaneous abortion, and congenital anomalies) in pregnant women. This issue was identified by three initial consumer complaints, with reports that the meters were presenting the incorrect unit of measure.

FDA root cause category: Reprocessing Controls

What the company is doing

Roche issued Urgent Medical Device Removal letter on 5/13/24 to US distributors, direct accounts, & end users. Letter states reason for recall, health risk and action to take: We ask all users of the Accu-Chek Guide blood glucose monitoring system to " Please check your meter to see if the display shows the appropriate measuring unit (mg/dL) " Please compare the serial number of your meter with the listed affected serial numbers to determine if it is impacted by this issue. Please see the affected serial numbers below. 92339920445 92340117408 92339920116 92339955415 92340120006 92339094787 92340116052 92340120057 92339744998 " Please stop using your Accu-Chek Guide meter if you notice that your product shows an incorrect measuring unit or the serial number is one of the listed impacted products and: " Please visit http://accu-chek.com/notices/UMDR-24-001 and enter your serial number. The form will provide instruction on how to proceed. Otherwise, you may contact our Roche Diabetes Care Accu-Chek Customer Care line at 1-800-858-8072 (Monday Friday from 8:00 a.m. ET - 8:00 p.m. ET). " Please keep this UMDR for future reference. UPDATE: The Canadian affiliate was informed of the issue with this serial number via video conference on 21 May 2024. The updated appendix was provided to the Canadian affiliate on 27 May 2024.

Recall details

Recall number
Z-2174-2024
Status
Open, Classified
Initiated by the company
May 13, 2024
Posted by the FDA
Jun 21, 2024
Recalling firm
Roche Diabetes Care, Inc.
Quantity
48 units
Product code
NBW
FDA submissions
K160944
Distribution
Nationwide and Worldwide

Product description

Accu-Chek Guide (SC) Kit -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. Product REF Number: 08453071001

Code information (models, lots, serial numbers)

GTIN: 00365702729100 Serial Numbers: US: 92339920445, 92340117408, 92339920116, 92339955415, 92340120006, 92339094787, 92340116052,92340120057, 92339744998. Canada:93040305146

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.

Sources and updates

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