Devices

Device Recall D10 Dual Program Reorder Pack

Model / Serial
Model number 220-0201; Kit Lot number/Expiration date: 20010663/Sept 2012; 20010665-A/Sept 2012; 20010665-B/Sept 2012; 20010665-C/Sept 2012. Elution Buffer Lot numbers: AA10434, AA10435; Exp 9/30/2012
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide -- USA (nationwide) including the states of: AR, CA, CT, FL, HI, IN, MD, MN, MO, MS, NJ, NY, OH, PA, RI, TX. and the countries of: Brazil, Canada, China, England, France, India, Italy, Mexico, New Zealand, and S. Korea.
Product Description
D-10 Dual Program Reorder Pack; || contains 400 HbA1c or 200 HbA2/F/A1c tests. Kits include Elution Buffer 1 and 2; Calibrator 1 & 2. || Bio-Rad Laboratories Inc. Hercules, CA. || Product Usage: || Short Proghram: D-10 Dual Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). || Extended Program: The Bio-Rad D-10 Dual Program is intended for the percent determination of hemoglobins A2, F, and A1c, and for the detection of abnormal hemoglobins in human whole blood using ion-exchange high-performance liquid chromatography (HPLC). || The Bio-Rad D-10 Dual Program is intended for Professional Use Only: For In-Vitro Diagnostic Use.
Manufacturer
Bio-Rad Laboratories Inc
1 Event
- Recall of Device Recall D10 Dual Program Reorder Pack

Manufacturer

Bio-Rad Laboratories Inc

Manufacturer Address
Bio-Rad Laboratories Inc, 4000 Alfred Nobel Dr, Hercules CA 94547-1803
Source
USFDA

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