G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
Reported: October 3, 2018 Initiated: July 13, 2018 #Z-3244-2018
Product Description
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
Reason for Recall
Analyzers were distributed with software which lacks a 510K
Details
- Recalling Firm
- Tosoh Bioscience Inc
- Units Affected
- 8 units
- Distribution
- US Nationwide Distribution in states of - CA, OK, VA 7 WI
- Location
- Grove City, OH
Frequently Asked Questions
What product was recalled? ▼
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.. Recalled by Tosoh Bioscience Inc. Units affected: 8 units.
Why was this product recalled? ▼
Analyzers were distributed with software which lacks a 510K
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 3, 2018. Severity: Moderate. Recall number: Z-3244-2018.
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