Recall Z-1812-2018 ยท N/A
Tosoh Bioscience Inc
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
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100304 | ST AIA PACK HBA1C Tosoh Bioscience, Inc., Aug 27, 2010 |