Recall Z-1809-2018 ยท LCP Assay, Glycosylated Hemoglobin
Tosoh Bioscience Inc
Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218 The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.
| Date | Mar 5, 2018 |
| Status | Terminated |
| Reason | The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient results. |
| Root cause | 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 recalli |
| Quantity | 6049 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100304 | ST AIA PACK HBA1C Tosoh Bioscience, Inc., Aug 27, 2010 |