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Background
Abbott's Precision Xtra is a blood glucose and blood β-Ketone monitoring medical device launched in 2000 and manufactured by Abbott Diabetes Care Incorporated. This device has had several releases and recalls throughout its manufacturing run; to find if your device was apart of any affected lots, you may search FDA reports on AccessData.FDA.gov.
This device is for the assay of blood using testing strips, which can be inserted into a data port/strip port found on the bottom of the device. These devices are used primarily by individuals with medical conditions affecting insulin levels such as Diabetes(Type 1 or 2), and provides an ease of access for on-the-spot testing when aided with testing strips and a lancing device.
The monitor itself is fairly simple to handle and navigate through, and was intended for use for both patients and medical staff.
Source: Abbott Investment, Acquirement of Therasense, Abbott Precision Xtra Manual provided by www.Manualslib.com
Identification
UDIs: 00093815998372 or 00093815988144 or 00093815715023
Abbott Store's SKU: #9881465
The Precision Xtra is a small, hand-held device almost 3 inches in length and around 2 inches in width. While it may be operated without sound, it has a Beeper feature.
Here are physical attributes found on the device:
Front: A Display Window, LCD with backlight capabilities, and 3 buttons as follows: Back button, Mode button, and Forward button.
Left Side: Backlight button.
Bottom: Strip Port.
Back: From the upper half, a slidable battery cover. On the bottom half, manufacturer's information, barcodes.
Source: Abbott Store: Precision Xtra, NIH's AccessGUDID(Global Unique Device Identification Database)
Technical Specifications
This device contains components the manufacturer expects the user to provide for functioning purposes, such as blood glucose test strips and blood β-Ketone test strips. These external products contain their own instructions on how users should interpret data when using Abbott's Precision Xtra and it is highly recommended that users read the instructions provided by these external products if the user will use them.
Size Dimensions:
- Length: 2.94 inches (7.47 cm)
- Width: 2.10 inches (5.33 cm) - 1.70 inches (4.32 cm)
- Thickness: 0.64 inches (1.63 cm)
Weight: 1.41-1.62 ounces (40-46 grams)
Power Source: 1 CR 2032 Lithium (coin cell) battery
Memory: UP to 450 events, including control results, personal blood glucose and blood β-Ketone results, and other monitor information
Storage Temperature:
- Meter: -13º to 131ºF (-25º to 55ºC)
- Test Strips/Control Solution: Separate products will contain their own instructions for use.
Functionals:
- Memory: 450 events
- Additional: Backlight, Beeper
Data Port: Available
Meter Operating Range:
- Temperature: 50º to 122ºF (10º to 50ºC)
- Relative Humidity: 10% to 90%, non-condensing
System Operating Range:
- Temperature: The system operating range is the operating range of the test strips used.
- Relative Humidity: 10% to 90%, non-condensing
Source: Abbott Precision Xtra Manual provided by www.Manualslib.com
Additional Information
FDA Device Recall (2007): Recall issued, affecting 300 lots: front button covers detaching from the meter. Terminated: April 04, 2008.
FDA Device Recall (2010): Recall issued, affecting 359 lots: monitor may display lower blood glucose result in error. Terminated: October 25, 2011.
FDA's Blood Monitoring Master Page
Background on Blood Monitoring Technology
For Abbott's Customer Service Line:
"Customer Service available Monday through Friday, 8AM to 8PM Eastern Standard Time at 1-800-527-3339 or visit us online at: AbbottDiabetesCare.com"
