Roche recalls Accu-Chek Guide (SC) Kit due to potential incorrect glucose unit display (mmol/L instead of mg/dL), risking mismanagement of diabetes and health complications.
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.
Roche is recalling Accu-Chek Guide (SC) glucose meters that may show glucose levels in millimoles per liter (mmol/L) instead of milligrams per deciliter (mg/dL). This error could lead to dangerous misinterpretation of blood sugar levels, potentially causing severe health issues like hyperglycemia and long-term diabetes complications.
The glucose meters may display readings in mmol/L instead of mg/dL, causing blood sugar levels to appear 18 times lower than they actually are. This could lead to incorrect treatment decisions, such as giving too much sugar when the person is actually hyperglycemic, which might cause serious health issues like diabetic complications or pregnancy problems.
People with diabetes who use the Accu-Chek Guide (SC) glucose meters are affected. Pregnant women using these meters could face risks to their pregnancy and fetal development.
Check the serial numbers on the product: US serial numbers include 92339920445, 92340117408, 92339920116, 92339955415, 92340120006, 92339094787, 92340116052, 92340120057, 92339744998. Canada serial numbers include 93040305146.
Look for US serial numbers starting with 92339920445, 92340117408, 92339920116, 92339955415, 92340120006, 92339094787, 92340116052, 92340120057, 92339744998 or Canada serial number 93040305146.
The recall is due to glucose meters showing readings in mmol/L instead of mg/dL, which could cause blood sugar levels to appear 18 times lower than they actually are, leading to incorrect treatment.
Incorrect readings could lead to inappropriate treatment for hypoglycemia, causing hyperglycemia. This might result in unrecognized diabetes complications like retinopathy, neuropathy, or pregnancy issues.
Check the serial numbers: US numbers include 92339920445, 92340117408, 92339920116, 92339955415, 92340120006, 92339094787, 92340116052, 92340120057, 92339744998. Canada number is 93040305146.
We’ve drafted a message you can send Roche to request your refund or repair — edit it as you like.
Subject: Recall Z-2174-2024 — Roche Roche Hello, I own a Roche that is covered by recall Z-2174-2024 from Roche. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
