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

d m gina dmgina at samobile.net
Sat Aug 31 18:44:43 UTC 2013

If this is true, then why am I doing so well by listening to my readings.
this is the meter that has worked well for me for years.
I question what they have to say.

Original message:
> 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

>> To visit our website click here: Diabetes Watchdog
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