FDA Medical Device Recalls (openFDA)
Tosoh Bioscience Inc: 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.
- Recall number
- Z-3244-2018
- Recalling firm
- Tosoh Bioscience Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2018-07-13
- Posted
- not on file
- Terminated
- 2020-07-08
- Reason
- Analyzers were distributed with software which lacks a 510K
- Root cause
- No Marketing Application
- Action
- On July 13, 2018, Tosoh Bioscience started to telephone customers to set up on-site visits. On July 16, 2018, Tosoh Bioscience began to issue URGENT MEDICAL DEVICE RECALL notices to customers via hand delivery. Immediate Actions to be taken by the Customer/User: - Thoroughly review the content of this letter with the Tosoh field service representative. - Allow the Tosoh field representative to verify the software version currently on your analyzer - If the software is v5.23, your analyzer needs no further action - If the software is v5.24, allow the Tosoh field representative to download all patient results from your analyzer, remove software version v5.24, and upload software version v5.23. - Continue to use your analyzer and report results with software v5.23 once these activities have been completed. - Complete and return the Acknowledgement Form to the Tosoh field representative. - File the Urgent Medical Device Recall notice with your laboratory records and forward the information to others in your laboratory. If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the analyzer, please contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764. Should you have any questions regarding this medical device recall, please feel free to contact Bernadette OConnell at (800) 248-6764 or by email at bernadette.oconnell@tosoh.com. She will be available to answer any questions Monday - Friday, from 9:00 AM to 5:00 PM (PST).
- Quantity
- 8 units
- Distribution
- US Nationwide Distribution in states of - CA, OK, VA 7 WI
- Lot, serial or model codes
- Serial Numbers: 14646304, 14917201, 14886112, 14616503, 14856212, 14887601, 14886212 & 14917201
- 510(k) numbers
- ["K131580"]
- PMA numbers
- not on file
- Product code
- LCP
- Firm FEI
- 3005529799
- Firm city
- Grove City
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28