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FDA (Device enforcement)Recalled 2019-09-30closedclass ii

Roche Diabetes Care, Inc.: Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended t

Is my product affected?

Blood Glucose Monitoring System, Model Number 07400870001 ACCU-CHEK GUIDE SAMPLE KIT MG/DL - Product Usage: The Accu-Chek Guide Blood Glucose Monitoring System is intended to quantitatively measure glucose in fresh capillary whole blood from the fingertip, palm, and upper arm as an aid in monitoring

  • UPC 07400870001
  • UPC 00365702702035

Check against the official notice below — it lists the full affected range.

What happened

Roche Diabetes Care, Inc. is recalling the Accu-Chek Guide Blood Glucose Monitoring System, Model Number 07400870001, due to potential power issues. The recall affects 318,678 units distributed nationwide in the US and in multiple countries worldwide. The affected devices are those with serial numbers below XXX11000001, where XXX represents the first three digits of the serial number.

The recall notice does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Potential power issues with the Accu-Chek¿ Guide Blood Glucose Monitoring System. Distribution: US Nationwide distribution and countries of AR, AT, AU, BE, BR, CA, CH, CL, DE, DK, EC, ES, FI, FR, GB, GR, HK, HR, ID, IN, IT, JP, KR, LB, LT, LU, MM, MY, NL, NO, PH, PK, PT, SE, SG, TH, TW, ZA. Quantity: 318,678 Lot/code info: Model Number : 07400870001 Device Identifier: 00365702702035 All serial numbers below XXX11000001 (where XXX is the first 3 digits of the serial number).

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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