Product Description
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests;
For the determination of Hemoglobin A1c in human whole blood. IVD
Contents:
1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer
2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer
3. Wash/Diluent 1 x 1600 mL Deionized water
4. Analytical cartridge - 1 cation exchange cartridge
5. Floppy Diskette 1-program parameters
6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water.
7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative.
8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid
9 Thermal paper - 1 roll
10. Instruction manual
Made in United States
Bio-Rad Laboratories, Hercules, CA 94547.
Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Reason for Recall
A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.
Action Details
Bio-Rad sent an Urgent Medical Device Correction letter on September 12, 2011, to all affected subsidiaries and customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discard all affected product in accordance with all local, state and federal disposal procedures. If customers distributed the product further they should direct their customers to discard all unused product.
Customers were asked to please translate (if necessary) the attached "Customer Medical Device Correction Response Form," customers should add their local contact information and distribute to all affected customers in their region by mail or fax.
Compile tracking documentation (e.g. Excel spreadsheet) for all customers who received the Medical Device Correction Letter.
Complete the "SUBSIDIARY MEDICAL DEVICE CORRECTION RESPONSE FORM" and fax to Bio-Rad Regulatory Affairs at (510) 741-3954, or e-mail PDF to CSD_RA/Hercules/US/BIO-RAD.
Customers would be issued credits for the affected products based on their request.
For questions call (510) 741-3954.
Distribution Pattern
Nationwide and to New Zealand, Canada, France, England, China, India, Mexico, Italy, Brazil, Australia, Singapore, Thailand, SriLanka, hong Kong, Sweden, Germany, Peru, Jamaica, Uruguay, Columbia, Argentina, Chile, Paraguay and Korea.
Code Information / Serial Numbers
Model number: 220-0101; Lot number/Expiry: 20010946. 11/30/12; 20011075, 11/30/12; Contain Buffer lot AA10888/AA10889, expiry 3/31/13; 20011077, 11/30/12; 20011079, 11/30/12; 20011081, 11/30/12. Contain Buffer lot AA10440/AA10441, expiry 2/28/13.
Public Record Disclaimer
This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.