[Diabetes-talk] Fwd: FDA Warning Letter Issued to Prodigy Diabetes care

[Vincent Chaney Jr]

Greetings to All:

FYI...

This FDA information and the link to the letter are an interesting read.
This may be something to consider if in the plans to buy a meter

Vincent
President DAN of New Jersey



Sent from my iPhone

Begin forwarded message:

> From: watchdog at diabeteswatchdog.org
> Date: August 30, 2013, 4:46:16 PM EDT
> To: vgc732 at optonline.net
> Subject: FDA Warning Letter Issued to Prodigy Diabetes care
> 
> The US Food and Drug Administration (FDA) published a written warning letter to Prodigy Diabetes Care identifying serious violations for the Prodigy Blood Glucose Test System, Prodigy Voice Blood Glucose Monitoring System, Prodigy Autocode Blood Glucose Meter, and Prodigy Pocket devices.  FDA inspected Prodigy facilities and cited numerous violations and  complaints that were not properly reported and that "reasonably suggests that Prodigy's device may have caused or contributed to a life threatening injury".  The letter goes onto detail failures in Prodigy's manufacturing processes, quality control processes, record keeping, and details test strip lots that were distributed by the company despite failing to meet accuracy standards. 
> 
> The letter can be read in its entirety on the FDA website: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm360148.htm#.UhYvg45gcaE.email
> 
>  
> 
> The Diabetes Watchdog
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> To visit our website click here: Diabetes Watchdog