Device recall: The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated…
Class II FDA enforcement event 80111. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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 bioMérieux 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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
BioMerieux SA started this device recall on 23 Mar 2018. The firm address in the FDA record is in Marcy L'Etoile. FDA put the recall in Class II. FDA event 80111 has 9 product records. The first FDA enforcement report date is 20 Jun 2018. The record gives the status Terminated, with the termination date 23 Jun 2020.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
International distribution.
Recalling firm
BioMerieux SA, Marcy L'Etoile, N/A, France.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
9 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2164-2018 | The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES A microorganism differentiation and identification… | 15 boxes with GP TEST KIT VTK2 20 CARDS | Class II | Terminated | 20 Jun 2018 |
| Z-2165-2018 | The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism differentiation and identification device is a… | 2 boxes of NH TEST KIT with 20 Cards | Class II | Terminated | 20 Jun 2018 |
| Z-2166-2018 | The VITEK 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK 2 ANC identification card is a single-use disposable. A microorganism… | 135 (78 boxes of various product) in total | Class II | Terminated | 20 Jun 2018 |
| Z-2167-2018 | The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents. Fully automated short-term incubation cycle antimicrobial… | 5 boxes with AST-P606 TEST KIT 20 CARDS | Class II | Terminated | 20 Jun 2018 |
| Z-2168-2018 | The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative bacilli to antimicrobial agents. Fully automated short-term incubation cycle antimicrobial… | 135 (78 boxes of various product) in total | Class II | Terminated | 20 Jun 2018 |
| Z-2169-2018 | 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… | 2 boxes VIDAS TOXO IGG AVIDITY 30 TESTS | Class II | Terminated | 20 Jun 2018 |
| Z-2170-2018 | The PREVI Color Gram dyes are used with the PREVI Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI Color Gram instrument sprays the PREVI Color Gram reagents onto microscope slides which have been smeared with specimens to be… | FUCHSIN-A (ref: 29522) 15 eaches; IODINE-B (ref: 29523) 10 eaches ; CRYSTAL VIOLET-C (ref: 29524) 10 eaches | Class II | Terminated | 20 Jun 2018 |
| Z-2171-2018 | Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues… | 8 boxes COLOR GRAM2 with 4 - 240ML bottles in each | Class II | Terminated | 20 Jun 2018 |
| Z-2172-2018 | Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the differentiation of Gram (-) bacilli (1, 2). A microorganism differentiation and identification… | 4 boxes of OXIDASE REAGENT with 50 - 0.75ML bottles | Class II | Terminated | 20 Jun 2018 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2018
- 1,074
- Share of these events in Class II
- 92%
- Product records in this event
- 9Median of the firm: 1
- Events of the firm on the register
- 21
Other events of the firm
Official channels
- FDA enforcement report Z-2164-2018The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 80111. https://recallregister.com/fda/ii/80111/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
International distribution.
- What quantity of product is in FDA event 80111?
- The event has 9 product records. The first record gives this quantity:
15 boxes with GP TEST KIT VTK2 20 CARDS
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2018 have the same class?
- 92% of the 1,074 device events that started in 2018 are in Class II.