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U.S. Department of Health and Human Services

Class 2 Device Recall Tosoh ST AIAPACK HbA1c Pretreatment Solution

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  Class 2 Device Recall Tosoh ST AIAPACK HbA1c Pretreatment Solution see related information
Date Initiated by Firm March 05, 2018
Create Date May 14, 2018
Recall Status1 Terminated 3 on June 16, 2020
Recall Number Z-1812-2018
Recall Event ID 79708
510(K)Number K100304  
Product Classification unknown device name - Product Code N/A
Product Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718

The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control set for the HbA1c assay
Code Information All lots.
Recalling Firm/
Tosoh Bioscience Inc
3600 Gantz Rd
Grove City OH 43123-1895
For Additional Information Contact Tosoh Technical Support
Manufacturer Reason
for Recall
The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results.
FDA Determined
Cause 2
Nonconforming Material/Component
Action On March 5, 2018, the firm notified all customers who have received product since 2011 of the discontinuation of this product from the market. Customers were instructed to immediately discontinue use of all lot numbers of recalled test and components, remove all recalled materials from inventory, and destroy per the customer's local procedures. Customers were also instructed to notify and forward the information to physicians who have received test results provided by recalled products over the past 6 months to determine if follow up testing is required. Customers were advised that the recalling firm is permanently removing all ST AIA-PACK HbA1c test and components from the market, and were instructed to identify an alternative test option for HbA1c. Customers were asked to complete and return the Recall Acknowledgement Form to the recalling firm. Customers may contact Tosoh Technical Support at 1(800)-248-6764, 8AM-5PM PST (voice mail after hours), seven days a week.
Quantity in Commerce 2258
Distribution USA (nationwide) Distribution including PR and to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MO, NC, NE, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

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 = N/A and Original Applicant = Tosoh BioScience, Inc.