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U.S. Department of Health and Human Services

Class 2 Device Recall KAssay(R) MultiAnalyte Calibrator

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 Class 2 Device Recall KAssay(R) MultiAnalyte Calibratorsee related information
Date Initiated by FirmJuly 19, 2017
Create DateOctober 20, 2017
Recall Status1 Terminated 3 on November 20, 2018
Recall NumberZ-3138-2017
Recall Event ID 77916
510(K)NumberK993853 
Product Classification Calibrator, multi-analyte mixture - Product Code JIX
ProductK-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
Code Information Lot Numbers: N653, N654, D755, D647, F648, F649, G650, J651, L652
FEI Number 2084025
Recalling Firm/
Manufacturer		 Kamiya Biomedical Company, LLC
12779 Gateway Dr S
Tukwila WA 98168-3308
For Additional Information ContactColin Getty
206-575-8068
Manufacturer 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 2		Under Investigation by firm
ActionKamiya 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 in Commerce1398 units
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = JIX
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