eGLU, 15ct., CCPlus Home REF 4755

• FDA 510(k) K140068 decided 22 May 2015 Active
• FDA GUDID UDI-DI 00381934755014 listed 20 Jun 2023 Listed

• 4 recalls, same reason

  • Terminated Z-0833-2020 FDA Class II ·initiated 2 Dec 2019
  • Terminated Z-0835-2020 FDA Class II ·initiated 2 Dec 2019
  • Terminated Z-0834-2020 FDA Class II ·initiated 2 Dec 2019
  • Terminated Z-0832-2020 FDA Class II ·initiated 2 Dec 2019

  One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.

1. 22 May 2015 Cleared FDA 510(k) K140068
2. 2 Dec 2019 Recall initiated FDA recalls Z-0833-2020
3. 2 Dec 2019 Recall initiated FDA recalls Z-0835-2020
4. 2 Dec 2019 Recall initiated FDA recalls Z-0834-2020
5. 2 Dec 2019 Recall initiated FDA recalls Z-0832-2020
6. 20 Jun 2023 Listed FDA GUDID 00381934755014

Trade name

eGLU, 15ct., CCPlus Home

Generic name

Multiple lipid analyte IVD, kit, multiple technologies

Model / Ref / Catalog

REF 4755

Primary DI / UDI-DI

00381934755014

510(k) Number

K140068 ↗

FDA product code

CGA, NBW

GMDN term

Multiple lipid analyte IVD, kit, multiple technologies

Device class

Class II

Regulation number

862.1345

GUDID distribution status

In Commercial Distribution

Category: Multiple lipid analyte IVD, kit, multiple technologies

Other devices filed under FDA product code CGA (GLUCOSE OXIDASE, GLUCOSE).

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• PRECISION Q I D BLOOD GLUCOSE TEST STRIPS by Medisense, Inc.
• MPX SYSTEM, GLUCOSE TEST SYSTEM by Lifescan, Inc.
• NOVOCHECK/CHECKPOINT/CONTROL SOLUTION by Garid, Inc.
• GLUCOSE-SUPER FAST 4983050 AND 4983500 by American Research Products Co.
• GLUCOSE REAGENT B6360-11 by American Scientific Products
• ABL90 FLEX PLUS System by Radiometer Medical ApS
• GLUCOSE TESTCARD USE W/ILEX PROMPT CLINICAL CH ANA by Medical Device Consultants, Inc.
• ACCUDEX REAGENT STRIPS by Miles Laboratories, Inc.

• CardioChek® Plus Professional Analyzer, Refurbished 2702

  Class I

  GUDID on market

• pts collect™ Capillary Tubes 2874

  Class I

  GUDID on market

• A1CNow® Self Check Test System 3070

  Class II

  FDA 510(k) K090413 Active Cleared 14 May 2009 GUDID on market

• CardioChek Plus Home Lipid Panel Self-Test Strip 2ct 4722

  Class I

  FDA 510(k) K151545 Active Cleared 22 Dec 2016 GUDID on market

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