Z-3138-2017Class II

K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The...

Name: Z-3138-2017 K-Assay(R) Multi-Analyte Calibrator, REF KAI--016C, KAMIYA BIOMEDICAL COMPANY, Seattle, WA, IVD The...
Creator: Kamiya Biomedical Company, LLC
Published: 2017-07-19
License: https://open.fda.gov/license/

Kamiya Biomedical Company, LLC / initiated 2017-07-19 / Terminated / root cause: labeling and UDI

FDA source

Kamiya Biomedical Company, LLC began a recall of 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... on 2017-07-19. FDA classified it as Class II and gives the reason as "The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3138-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-19
Posted: 2017-10-20
Terminated: 2018-11-20
Recalling firm: Kamiya Biomedical Company, LLC
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
Product code: JIX Calibrator, Multi-Analyte Mixture
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: Lot Numbers: N653, N654, D755, D647, F648, F649, G650, J651, L652

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3138-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3138-2017	Class II	Terminated	Voluntary: Firm initiated	2017-09-27	2017-10-20

Product code JIX

K993853Class IIK-Assay Multi-Analyte CalibratorKamiya Biomedical Co. / cleared 1999-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)