Recall Z-0923-2011
Kamiya Biomedical Company, LLC · initiated September 17, 2008
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...".
Codes / lots: Lot number 418041, catalog number KAI-056.
Reason for recall
Standardization of the reagent performance data did not match the standardization used to assign the calibrator values.
FDA-determined cause: Employee error
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.
Details
- Recall number
- Z-0923-2011
- Initiated
- September 17, 2008
- Posted by FDA
- January 19, 2011
- Terminated
- January 20, 2011
- Product code
- MGA – Alpha-1 Microglobulin, Antigen, Antiserum, Control
- Quantity
- 5 kits
- Distribution
- Kits were distributed to one laboratory in MN and to one distributor in PA who further distributed product to one customer.
- Recalling firm
- Kamiya Biomedical Company, LLC, Tukwila, WA