Z-0923-2011

K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent...

Name: Z-0923-2011 K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent...
Creator: Kamiya Biomedical Company, LLC
Published: 2008-09-17
License: https://open.fda.gov/license/

Kamiya Biomedical Company, LLC / initiated 2008-09-17 / Terminated / root cause: manufacturing process

FDA source

Kamiya Biomedical Company, LLC began a recall of K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged... on 2008-09-17. The reason FDA records is "Standardization of the reagent performance data did not match the standardization used to assign the calibrator values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0923-2011
Status: Terminated
Initiated: 2008-09-17
Posted: 2011-01-19
Terminated: 2011-01-20
Recalling firm: Kamiya Biomedical Company, LLC
Product: K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody Reagent 50 mL. The product is packaged in a kit box along with with the package insert. The package insert is labeled in part: "K-ASSAY Alpha-1 Microglobulin...Cat. No. KAI-056...For the Quantitative Determination of human Alpha-1 Microglobulin in urine, serum, and plasma...KAMIYA BIOMEDICAL COMPANY...12779 Gateway Drive...Seattle, WA 98168 USA...".
Product code: MGA Alpha-1 Microglobulin, Antigen, Antiserum, Control
Reason for recall: Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Kamiya Biomedical Company, LLC sent an urgent medical Device Recall letter dated September 17, 2008, and the corrected package insert via e-mail. . The letter identified the product, the problem, and the action the customer should take. Customers were instructed to replace their previous package inserts with the corrected version and asked to sign and FAX the letter back once that had been completed. As one customer is also a distributor, the recalling firm told the this distributor's representative to advise their single customer of this correction and replace the package insert, and return the signed letter back to the firm. On September 22, 2008, both customers were contacted by phone and reminded to fax the signed letters once completed. For questions regarding this recall call 1-800-222-0342.
Quantity in commerce: 5 kits
Distribution: Kits were distributed to one laboratory in MN and to one distributor in PA who further distributed product to one customer.
Product codes and lots: Lot number 418041, catalog number KAI-056.

Product code MGA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)