ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
This recall has been terminated (originally issued November 30, 2018).
- Company
- Tosoh Bioscience Inc
- Recall Initiated
- November 30, 2018
- Terminated
- January 14, 2021
- Recall Number
- Z-0674-2019
- Quantity
- 26745 units
- Firm Location
- Grove City, OH
- Official Source
- View on FDA website ↗
Distribution
US Nationwide
Lot / Code Info
all lots
Root Cause
Device Design
Action Taken
On November 30, 2018, Tosoh Bioscience issued Urgent Medical Device Recall notices to customers. Customers are advised to take the following actions: " Do not use the assays identified in notice for those patients who have recently had a fluorescein angiography procedure. For these patients, use an alternative testing method that does not use a fluorescein-based technology. " Inform medical professionals that the Tosoh AIA assays in the notice utilize a fluorescein-based technology and should not be used to test patient samples for patients who have recently undergone fluorescein angiography. " Continue to use the Tosoh AIA assays listed in notice only for patients who have not undergone a fluorescein angiography procedure exam, or on patient samples which have been taken prior to receiving the fluorescein angiography procedure. " Complete & return the Urgent Medical Device Recall Acknowledgement Form within 15-days of receiving the notification. " Maintain a copy of the notification with your laboratory records and forward this information to others who may have received this product. Should you have any questions, please contact Bernadette OConnell at 1(800) 248-6764 or by email at Bernadette.oconnell@tosoh.com. She will be able to answer any questions Monday-Friday from 9 AM to 5 PM (PST).