G8 Automated HPLC Analyzer: HLC-723G8-ST recall: Software Issue
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is…
Why was G8 Automated HPLC Analyzer: HLC-723G8-ST recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All active analyzers with Version 5.23 Software
- Product
- G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is…
- Recalling firm
- Tosoh Bioscience Inc
- 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.
- Recall date
- August 22, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)