Recall Z-3138-2017 ยท JIX Calibrator, Multi-Analyte Mixture
Kamiya Biomedical Company, LLC
K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The K-ASSAY(R) Multi-Analyte Calibrator is intended to be used for the calibration of the K-ASSAY(R) Alpha-1 Acid Glycoprotein, Alpha-1 Anti-Trypsin, Complement C3, Complement C4, Haptoglobin, lgA, lgG, lgM, and Transferrin immunoturbidimetric assays. For in vitro diagnostic use
| Date | Jul 19, 2017 |
| Status | Terminated |
| Reason | The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct. |
| Root cause | Under Investigation by firm |
| Action | Kamiya Biomedical Company sent an Urgent Medical Device Recall/Correction Notice on July 14, 2017 to affected customers, providing them with updated package inserts with corrected A1AT values and/or free replacement kits. Customers were asked to fill in and return the acknowledgement form. Customers with questions were instructed to contact the firm at 206-575-8068. |
| Quantity | 1398 units |
| Distribution | Worldwide Distribution - US including FL, CA, WA, OH, IA, IL, NJ, NY, NC, MA, TX, CT, MD, VA, Internationally to TN, Czech Republic, Taiwan, Dominican Republic, Switzerland, China, and Jamaica |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993853 | K-ASSAY MULTI-ANALYTE CALIBRATOR Kamiya Biomedical Co., Dec 27, 1999 |