Recall Z-1396-2009 ยท DDR Myoglobin, Antigen, Antiserum, Control
Beckman Coulter Inc
Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems.
| Date | May 22, 2009 (initiated Sep 27, 2007) |
| Status | Terminated |
| Reason | Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determined that the total imprecision for the Access Myoglobin Reagent is greater than or equal to 10% across the expected physiological range rather than the stated claim less than 8%. Based on internal tes |
| Root cause | Labeling False and Misleading |
| Action | An Urgent: Product Corrective Action (PCA) letter was mailed via US Postal Service on October 08, 2007 to the customers that received Access Myoglobin Reagent kits informing them about the issue. The letter also informed customers that the product insert in the Access Assay Manual will be revised with the new range to reflect the new imprecision claim. Customers were instructed to: (1) Share this information with their laboratory staff and retain the letter for their Quality System documentation, (2) Complete and return the enclosed fax-back response form within 10 days so that Beckman Coul |
| Quantity | 20,727 |
| Distribution | Nationwide and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021229 | MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 Beckman Coulter, Inc., Jun 28, 2002 |