Recall Z-3138-2017
Kamiya Biomedical Company, LLC · initiated July 19, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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
Codes / lots: Lot Numbers: N653, N654, D755, D647, F648, F649, G650, J651, L652
Reason for recall
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-3138-2017
- Initiated
- July 19, 2017
- Terminated
- November 20, 2018
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- 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
- Recalling firm
- Kamiya Biomedical Company, LLC, Tukwila, WA