Accu-Chek Guide 07400942001
by Roche Diagnostics Operations, Inc.
Accu-Chek Guide 07400942001 is a glucose IVD (FDA Class II; FDA product code NBW, System, Test, Blood Glucose, Over The Counter) made by Roche Diagnostics Operations, Inc., cleared under FDA 510(k) K160944 on 31 Aug 2016 and listed in FDA GUDID since 2 Feb 2017 (UDI-DI 00365702702066), active as of 23 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00365702702066 | Date2 Feb 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160944 | Date31 Aug 2016 | StatusActive |
Official records
- AccessGUDID record 00365702702066
- FDA 510(k) database K160944
Across registries
- FDA 510(k) K160944 decided 31 Aug 2016 Active
- FDA GUDID UDI-DI 00365702702066 listed 2 Feb 2017 Listed
Recalls
-
- Ongoing Z-2174-2024
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.
-
- Terminated Z-0747-2020
Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.
Timeline
- Cleared FDA 510(k) K160944
- Listed FDA GUDID 00365702702066
- Recall initiated FDA recalls Z-0747-2020
- Recall initiated FDA recalls Z-2174-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Accu-Chek Guide
- Generic name
- Glucose IVD, kit, spectrophotometry
- Model / Ref / Catalog
- 07400942001
- Primary DI / UDI-DI
- 00365702702066
- 510(k) Number
- FDA product code
- NBW
- GMDN term
- Glucose IVD, kit, spectrophotometry
- Device class
- Class II
- Regulation number
- 862.1345
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Glucose IVD, kit, spectrophotometry.