Recall Z-2745-2018 ยท LCP Assay, Glycosylated Hemoglobin
Tosoh Bioscience Inc
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in iden
| Date | Jun 6, 2018 |
| Status | Terminated |
| Reason | HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Customers should exercise caution when reviewing chromatograms and ensure that Flag 43 is enabled on their device to avoid reporting invalid test results in the presence of HbAE. |
| Root cause | Software design |
| Action | The firm issued an Urgent Medical Device Recall letter to its affected customers on June 6, 2018. In the notice, Tosoh is currently investigating a resolution to this issue to eliminate interference from hemoglobin variants. In the interim, customers should carefully review the chromatography to determine whether or not a variant peak is detected and follow the recommendations included in the letter. Customers were asked to complete and return the attached Acknowledgement Form and the flag setting confirmation to Tosoh Bioscience, Inc., within 14-days of receiving this notification by FAX |
| Quantity | 665 |
| Distribution | Worldwide Distributed - US Nationwide. and the countries of Foreign distribution to Brazil, Caribbean, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Panama, Peru, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100304 | ST AIA PACK HBA1C Tosoh Bioscience, Inc., Aug 27, 2010 |