Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 20, 2018
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 anti
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
BioMerieux Sa recalled VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instr… - a moderate-severity action.
VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instr… was recalled by BioMerieux Sa in June 20, 2018. Reason: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Aft…. Check the official notice for the remedy. Verify recall #Z-2169-2018 with the FDA Devices before acting.
The recall
BioMerieux Sa issued this moderate-severity FDA Devices recall-A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. Aft….
- Moderate
- severity level
- Class II
- classification
- June 20, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2169-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2169-2018) was formally reported on June 20, 2018, with the manufacturer initiating the action on March 23, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. BioMerieux Sa is listed as the recalling firm, operating out of Marcy L'Etoile, N/A. Federal records list the affected scope as 2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS.
The documented reason for this recall is: A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux distributor in Guadeloupe to put produc… Distribution data in the federal record shows the product reached: International distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS
Related Recalls
6
3 from same agency
Product 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.
Reason for recall
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2169-2018 |
| Date reported | June 20, 2018 |
| Date initiated | March 23, 2018 |
| Recalling firm | BioMerieux Sa |
| Firm location | Marcy L'Etoile, N/A |
| Affected scope | 2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS |
| Distribution | International distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2169-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by BioMerieux Sa. Units affected: 2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS.
Why was this product recalled? ▼
A shipment to Guadeloupe suffered a temperature excursions up to 47.8¿C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioM¿rieux 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 20, 2018. Severity: Moderate. Recall number: Z-2169-2018.
Where was the recalled product distributed? ▼
Distribution: International distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2169-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 20, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.