AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
Recall
- Recall Number
- Z-0672-2019
- Event Number
- 81597
- Firm
- Tosoh Bioscience Inc
- FEI Number
- 3005529799
- Product Code
- CGN
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- November 30, 2018
- Terminated
- January 14, 2021
- Address
- 3600 Gantz Rd, Grove City, OH, 43123-1895
Description
AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.
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 [email protected]. She will be able to answer any questions Monday-Friday from 9 AM to 5 PM (PST).
US Nationwide
19366 units