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U.S. Department of Health and Human Services

Class 2 Device Recall STAIA PACK AFP

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  Class 2 Device Recall STAIA PACK AFP see related information
Date Initiated by Firm March 05, 2018
Create Date June 05, 2018
Recall Status1 Terminated 3 on August 31, 2020
Recall Number Z-2065-2018
Recall Event ID 79813
510(K)Number K023894  
Product Classification Kit, test,alpha-fetoprotein for testicular cancer - Product Code LOJ
Product ST-AIA PACK AFP; Part Number: 025252

Assay, Tumor Marker
Code Information All Lot Codes
Recalling Firm/
Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact
Manufacturer Reason
for Recall
Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
FDA Determined
Cause 2
Device Design
Action The firm TOSOH Bioscience Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 23, 2018 to affected customers. The letter described the product, problem and action to be taken. The customers were instructed to do the following: *Based on our revised labeling, the assays identified in Table 1 should not be used for patients who are being treated with Asfotase Alfa. " For patients that are being treated with Asfotase Alfa, use an alternative test method that does not utilize alkaline phosphatase technology. " Inform all medical professionals that assays utilizing alkaline phosphatase-based technologies must not be used for patients receiving Asfotase Alfa treatment. Continue to use the assays listed in Table 1 for any patients who are not receiving Asfotase Alfa treatment. " Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification via Fax: 1-650-636-8651, Email: biorecallresponse@tosoh.com or Regular mail: 3600 Gantz Rd., Grove City, OH 43123. " Maintain this notification with your laboratory records and forward this information to others who may have received this product. " If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to call (800) 248-6764 or email: bernadette.oconnell@tosoh.com. Monday - Friday, from 9:00 AM to 5:00 PM (PST).
Quantity in Commerce 3254
Distribution Worldwide Distribution: US (Nationwide) and countries of; Canada, Mexico, Columbia, Chile, Uruguay, Nicaragua, Argentina, Peru, Chile, Honduras. Equador, Caymen Islands, Panama, and Costa Rica.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LOJ and Original Applicant = TOSOH MEDICS, INC.