Z-2169-2018Class II

VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the...

Name: Z-2169-2018 VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the...
Creator: BioMerieux SA
Published: 2018-03-23
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2018-03-23 / Terminated / root cause: manufacturing process

FDA source

BioMerieux SA began a recall of 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... on 2018-03-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2169-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-23
Posted: 2018-06-12
Terminated: 2020-06-23
Recalling firm: bioMerieux, Inc.
Product: 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.
Product code: LGD Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Environmental control
Action: 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].
Quantity in commerce: 2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS
Distribution: International distribution.
Product codes and lots: VIDAS¿ TOXO IgG AVIDITY (ref: 30222): Lot Number 1005621420

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2169-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2164-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2165-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2166-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2167-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2168-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2169-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2170-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2171-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12
Z-2172-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-20	2018-06-12

Product code LGD

K101946Class IIVidas Toxo Igg AviditybioMerieux, Inc. / cleared 2011-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)