K-ASSAY Alpha-1 Microglobulin Reagent Kit. Kit contains: 1 vial Reagent 1, Buffer 50 mL, and 1 vial reagent 2, Antibody

FDA device recall Z-0923-2011 · posted 2011-01-19 · Terminated

Recall details

Recalling firm

Kamiya Biomedical Company, LLC

Reason for recall

Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.

Action taken

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.

Root cause

Employee error

Status

Terminated

Product code

MGA

Quantity affected

5 kits

Distribution

Kits were distributed to one laboratory in MN and to one distributor in PA who further distributed product to one customer.

Date initiated

2008-09-17

Date posted

2011-01-19

Date terminated

2011-01-20

Location

Tukwila, WA