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Class 3 Device Recall VARIANT Bthalassemia Short Program Reorder Pack, 250 Tests |
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Date Initiated by Firm |
September 12, 2011 |
Date Posted |
October 07, 2011 |
Recall Status1 |
Terminated 3 on May 11, 2012 |
Recall Number |
Z-0023-2012 |
Recall Event ID |
59868 |
510(K)Number |
K991127
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Product Classification |
Hemoglobin a2 quantitation - Product Code LCP
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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) |
Code Information |
Model number: 270-2103; Lot number 70210959, expiry 6/30/12. Contains Buffer Lot number AA10685/AA10686, expiry 3/31/11. |
Recalling Firm/ Manufacturer |
Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules CA 94547-1803
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For Additional Information Contact |
Jackie Buckley 510-741-5309
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Manufacturer 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.
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FDA Determined Cause 2 |
Process control |
Action |
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. |
Quantity in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = LCP and Original Applicant = BIO-RAD
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