Reported Mar 1, 2017 · Terminated
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
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. · 6000 Shoreline Ct Ste 101 · South San Francisco, CA · 94080-7606
Is this the product you have?
- Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
- Lot codes and dates
- All active analyzers
- Amount recalled
- 682 analyzers
Where it was sold
Why it was recalled
The device defect associated with this recall may result in HbA1c values with a negative bias in patients with the hemoglobin variants C, D, E and S. The negative bias occurs at the higher levels of HbA1c, e.g. 9%, but not at the diagnostic medical decision point of 6.5%.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Tosoh Bioscience, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.