Recall Z-1225-2017— Tosoh Bioscience, Inc.
Class II · Terminated
Class II FDA medical device recall by Tosoh Bioscience, Inc., initiated 2016-11-07, terminated 2021-02-09. It names 2 FDA 510(k) clearances: K131580, K071132. Product: Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.. Reason: 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%..
- Recalling firm
- Tosoh Bioscience, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-07
- Terminated
- 2021-02-09
- Firm location
- South San Francisco, CA, United States
510(k) clearances named in this recall
2 on FDA's record- K131580 — AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8
- K071132 — G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
Reason for recall
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%.
Data sourced from openFDA. This site is unofficial and independent of the FDA.