Recall Z-0023-2012
Bio-Rad Laboratories, Inc. · initiated September 12, 2011
Product
VARIANT B-thalassemia Short Program Reorder Pack, 250 Tests, For the separation and determination os HbA and HbF and as an aid in the identification of abnormal hemoglobins in whole blood. IVD, Made in United States. Contents: 1. Elution Buffer 1, 2 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 1 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 1 x 1800 mL deionized water 4. Analytical cartridge, 1 cation exchange cartridge 5. 1 Calibrator/Diluent set, 1 Lypholized human red blood cells hemolysate with preservative; deionized water with preservative 6. 1 CD Rom - CD R with program parameters 7 Sample vials, 100 x 1.5 mL. Sample vials with pierceable cap 8. Whole Blood Primer, 10 x 1.0 mL (3), Lypholized human red blood cells hemolysate with preservative; 9. Instruction Manual Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Codes / lots: Model number: 270-2103; Lot number 70210959, expiry 6/30/12. Contains Buffer Lot number AA10685/AA10686, expiry 3/31/11.
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-0023-2012
- Initiated
- September 12, 2011
- Posted by FDA
- October 7, 2011
- Terminated
- May 11, 2012
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Quantity
- 22
- Distribution
- 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.
- Recalling firm
- Bio-Rad Laboratories, Inc., Hercules, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0017-2012 | D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0018-2012 | D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547.…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0019-2012 | D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547.…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0020-2012 | VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0021-2012 | VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0022-2012 | VARIANT II TURBO Hemoglobin A1c Program Buffer B, Made in United States. Bio-Rad…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0024-2012 | VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0025-2012 | VARIANT / VARIANT II B-thalassemia Short Program Elution Buffer 2,. Made in United…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0026-2012 | VARIANT II TURBO LINK Hemoglobin A1c Program Buffer Set. Made in United States. Bio-Rad…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |
| Z-0027-2012 | VARIANT II TURBO LINK Hemoglobin A1c Program Reorder Pack, 1600 tests. For the…A previous recall related to reports of calibration failure and late retention times using Elution Buffer… | 09/12/2011Terminated |