FDA Device recall Z-2174-2024

Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm…

• FDA Device
• Class II
• ongoing
• Published 2024-07-03

On 2024-07-03 the FDA classified a Class II recall of Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm… by Roche Diabetes Care, citing 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….

Read the official FDA Device notice

Product

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

Reason

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Other recalls by Roche Diabetes Care

• RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001
  FDA Device · Class II · 2022-05-04 · Roche Diabetes Care
• Accu-Chek SmartView Test Strip, Blood Glucose Monitoring System, Model numbers: 06337538001, 06337546001, 06337562001
  FDA Device · Class II · 2021-09-01 · Roche Diabetes Care
• Accu-Chek Inform II Test Strip, Whole Blood Glucose Test System, Model number 05942891001
  FDA Device · Class II · 2021-09-01 · Roche Diabetes Care
• Accu-Chek Performa Test Strip, Blood Glucose Monitoring System, Model number 07299702001
  FDA Device · Class II · 2021-09-01 · Roche Diabetes Care
• Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 069083…
  FDA Device · Class II · 2021-09-01 · Roche Diabetes Care

All Roche Diabetes Care recalls

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2174-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.