VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens.
Recall
- Recall Number
- Z-2169-2018
- Event Number
- 80111
- Firm
- BioMerieux SA Chemin De L'Orme Marcy L'Etoile France
- FEI Number
- 1000611339
- Product Code
- LGD
- Status
- Terminated
- Root Cause
- Environmental control
- Initiated
- March 23, 2018
- Terminated
- June 23, 2020
Description
VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens.
A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux distributor in Guadeloupe to put products in quarantine in July 2017; After several reminders, the distributor informed in November 2017 that products were delivered to customers.
The firm, Biomerieux, sent an "Urgent product removal notice" letter on April 23 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1. Immediately acknowledge receipt (AR) of this FSCA. 2. Identify all countries and customers for which you are responsible that are impacted by this FSCA. 3. Define additional actions required (e.g. Translate customer letter, send to impacted countries/customers, etc.) 4. Distribute the customer letter to all customers that have received the products 5. Discard any impacted product remaining in local inventory 6. After all actions above are complete, please return the acknowledgement of completion (AC) for this FSCA. The due date for completion of the required actions and submitting the AC is 23-APR-2018 Subsidiaries Subsidiaries using SAP, please manage both the Acknowledgment of Receipt and the Acknowledgment of Completion of activities in SAP. Subsidiaries not using SAP, please immediately upload the Acknowledgement of Receipt in LiveLink after signing and completing sections #1 and #2. Section #3 must be signed, completed and uploaded in LiveLink before the due date. Distributors Please immediately Acknowledge Receipt of this FSCA by completing sections #1 and #2 of the acknowledgement form and sending it by email to [email protected] or by fax to +33 4 78 87 21 79. Please remember to sign and complete all of sections #1 and #2. Sections #1 and #3 must be signed, completed, faxed or emailed before the due date. If you have any questions, contact the Specialist, Regulatory & Quality Compliance at +33 4 78 87 56 16 or email to: [email protected].
International distribution.
2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS