Key facts
| Recalling firm | Roche Diabetes Care, Inc. |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| 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 |
| Classification | Class II |
| Recall number | Z-2174-2024 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| Reason for recall | 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. |
What this classification means
A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class II, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.
What consumers should do
Facilities, clinicians, and consumers holding an affected unit or lot of 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 should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Roche Diabetes Care, Inc.. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Roche Diabetes Care, Inc. should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Roche Diabetes Care, Inc. directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.
Roche Diabetes Care, Inc.’s FDA history
Argus HQ has recorded 1 total FDA action tied to Roche Diabetes Care, Inc.: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- Has Roche Diabetes Care, Inc. had other FDA recalls or enforcement actions?
- This is the only FDA action Argus HQ has on file for Roche Diabetes Care, Inc. so far. Argus ingests new FDA enforcement records daily.
- What is the FDA recall number for this event?
- FDA recall number Z-2174-2024.
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
- Where can I verify this recall directly with FDA?
- The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
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Related enforcement actions
Full FDA history for Roche Diabetes Care, Inc.Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2024). FDA Recall Database: Class II Recall: Accu-Chek Guide (SC) Kit -Intended to quantitatively measure… by Roche Diabetes Care, Inc.. Digital Empire LLC. Retrieved from https://argushq.ai/recall/roche-diabetes-care-z-2174-2024-2024-07-03
"FDA Recall Database: Class II Recall: Accu-Chek Guide (SC) Kit -Intended to quantitatively measure… by Roche Diabetes Care, Inc.." Argus HQ Research, Digital Empire LLC, 2024, argushq.ai/recall/roche-diabetes-care-z-2174-2024-2024-07-03.
Argus HQ Research. "FDA Recall Database: Class II Recall: Accu-Chek Guide (SC) Kit -Intended to quantitatively measure… by Roche Diabetes Care, Inc.." Digital Empire LLC. Accessed July 17, 2026. https://argushq.ai/recall/roche-diabetes-care-z-2174-2024-2024-07-03.
@misc{argushq_argushq_ai_recall_roche_diabetes_care_z_2174_2024_2024_07_03_2024,
title = {FDA Recall Database: Class II Recall: Accu-Chek Guide (SC) Kit -Intended to quantitatively measure… by Roche Diabetes Care, Inc.},
author = {{Argus HQ Research}},
year = {2024},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/recall/roche-diabetes-care-z-2174-2024-2024-07-03},
note = {Accessed: July 17, 2026}
}Source: FDA.gov — Recalls ↗