Recall Z-0024-2012 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories, Inc.
VARIANT B-thalassemia Short Program Reorder Pack, 500 Tests, For the separation and determination of 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, 3 x 1900 mL sodium phosphate buffer 2. Elution Buffer 2, 2 x 1800 mL sodium phosphate buffer 3. Wash/Diluent solution, 2 x 1800 mL deionized water
| Date | Oct 7, 2011 (initiated Sep 12, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 491 lot 70210674; 298 lot 70210954; 136 lot 70010957 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991127 | VARIANT II B-THALASSEMIA Bio-Rad, Jun 10, 1999 |