Reported Aug 22, 2018 · Terminated
G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 Product Usage: The Tosoh Automated…
Tosoh Bioscience Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tosoh Bioscience Inc · 3600 Gantz Rd · Grove City, OH · 43123-1895
Is this the product you have?
- G8 Automated HPLC Analyzer
HLC-723G8-ST021560and HLC-723G8-LA021674
- Product UsageThe 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 identifying patients who may be at risk for developing diabetes
- Lot codes and dates
- All active analyzers with Version 5.23 Software
- Amount recalled
- 665
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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