Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 3, 2024
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
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Roche Diabetes Care, Inc. recalled Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary w… - a moderate-severity action.
Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in fresh capillary w… was recalled by Roche Diabetes Care, Inc. in July 3, 2024. Reason: The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may…. Check the official notice for the remedy. Verify recall #Z-2174-2024 with the FDA Devices before acting.
The recall
Roche Diabetes Care, Inc. issued this moderate-severity FDA Devices recall — The reason for recall is the meters may show an incorrect measurement unit (mmol/L rather than mg/dL) and may….
- Moderate
- severity level
- 48 units
- affected scope
- Class II
- classification
- July 3, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2174-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2174-2024) was formally reported on July 3, 2024, with the manufacturer initiating the action on May 13, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Roche Diabetes Care, Inc. is listed as the recalling firm, operating out of Indianapolis, IN. Federal records list the affected scope as 48 units.
The documented reason for this recall is: 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 appro… Distribution data in the federal record shows the product reached: Nationwide and Worldwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
48 units
Related Recalls
6
6 from same agency
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2174-2024 |
| Date reported | July 3, 2024 |
| Date initiated | May 13, 2024 |
| Recalling firm | Roche Diabetes Care, Inc. |
| Firm location | Indianapolis, IN |
| Affected scope | 48 units |
| Distribution | Nationwide and Worldwide |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2174-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Roche Diabetes Care, Inc.. Units affected: 48 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 3, 2024. Severity: Moderate. Recall number: Z-2174-2024.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Worldwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2174-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 3, 2024.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.