Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing recall
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
Why was Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing 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%.
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
- Product
- Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
- Recalling firm
- Tosoh Bioscience, Inc.
- Quantity
- 682 analyzers
- Distribution
- Worldwide distribution. The products were shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, AND WY. The recalled products were shipped to the following countries: Brazil, Chile, Columbia, Guatemala, Costa Rica, Dominican Republic, Eduador, Nicaragua, Panama, Peru, Puerto Rico, Uruguay,
- Recall date
- March 1, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)