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Accu-Chek Guide 08256292001

by Roche Diagnostics Operations, Inc.

Accu-Chek Guide 08256292001 is a glucose IVD (FDA Class II; FDA product code LFR, Glucose Dehydrogenase, Glucose) made by Roche Diagnostics Operations, Inc., cleared under FDA 510(k) K160944 on 31 Aug 2016 and listed in FDA GUDID since 5 Dec 2017 (UDI-DI 00365702719101), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K160944; other models may be affected

Documents

510(k) K160944

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00365702719101 UDI-DI Date5 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160944 Date31 Aug 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160944 decided 31 Aug 2016 Active
  • FDA GUDID UDI-DI 00365702719101 listed 5 Dec 2017 Listed

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-2174-2024 FDA Class II initiated 13 May 2024 on shared 510(k) K160944

    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 FDA Class II initiated 30 Sep 2019 on shared 510(k) K160944

    Potential power issues with the Accu-Chek Guide Blood Glucose Monitoring System.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K160944
  2. Listed FDA GUDID 00365702719101
  3. Recall initiated FDA recalls Z-0747-2020
  4. Recall initiated FDA recalls Z-2174-2024

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Accu-Chek Guide
Generic name
Glucose IVD, reagent
Model / reference
08256292001
Primary DI / UDI-DI
00365702719101
510(k) Number
FDA product code
LFR
GMDN term
Glucose IVD, reagent
Device class
Class II
Regulation number
862.1345
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glucose IVD, reagent

Cleared under the same submission (K160944)

and 8 more cleared under K160944

Similar devices

Other devices filed under FDA product code LFR (Glucose Dehydrogenase, Glucose).

Other devices from Roche Diagnostics Operations, Inc.

See all devices from Roche Diagnostics Operations, Inc. →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)