G8 Automated HPLC Analyzer - 723G8 Product Usage - In recall: Software Issue
G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood…
Why was G8 Automated HPLC Analyzer - 723G8 Product Usage - In recalled?
Analyzers were distributed with software which lacks a 510K
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?
Serial Numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212 & 14917201
- Product
- G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood…
- Recalling firm
- Tosoh Bioscience Inc
- Quantity
- 8 units
- Distribution
- US Nationwide Distribution in states of - CA, OK, VA 7 WI
- Recall date
- October 3, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)