Device recall: ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized…
Class II FDA enforcement event 66931. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
bioMérieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493); leading to a false negative results of some API biochemical tests using the ZYM B reagent.
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 France Chemin De L'Or started this device recall on 8 Nov 2013. The firm address in the FDA record is in Marcy L'Etoile. FDA put the recall in Class II. FDA event 66931 has 3 product records. The first FDA enforcement report date is 5 Feb 2014. The record gives the status Terminated, with the termination date 30 Nov 2017.
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.
Worldwide Distribution - USA (nationwide) and Internationally to U.S. Nationwide; Algerie, Argentina, Armenia, Australia, Austria, Azerbaidjian, Bahrain, Bangladesh, Belarus, Belgium, Benin,…
Recalling firm
Biomerieux France Chemin De L'Or, Marcy L'Etoile, France.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0841-2014 | ZYM B Reagent (REF 70493) ZYM B reagent is an additional test used to reveal the results of some miniaturized biochemical test included in the API strips. The API product line is a standardized system combining several biochemical tests, which enables group or species identifications of microorganisms. | 39439 kits (includes ZYM B reagents, API Listeria * API NH kits) | Class II | Terminated | 5 Feb 2014 |
| Z-0842-2014 | API Listeria (REF 10300) API Listeria is a standardized system for the identification of Listeria which uses miniaturized tests, as well as a database. The ZYM B reagent is including in API Listeria kit and it is used as an additional reagent for revealing the result of DIM miniaturized biochemical test included in… | 39439 kits (includes ZYM B reagents, API Listeria * API NH kits) | Class II | Terminated | 5 Feb 2014 |
| Z-0843-2014 | API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis (Branhamella catarrhalis), which uses miniaturized tests, as well as a specially adapted database. API NH also enables the biotyping of Haemophilus influenza and… | 39439 kits (includes ZYM B reagents, API Listeria * API NH kits) | Class II | Terminated | 5 Feb 2014 |
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 2013
- 1,236
- Share of these events in Class II
- 90%
- Product records in this event
- 3Median of the firm: 3
- Events of the firm on the register
- 2
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 15 Apr 2016 | VIDAS NT-pro-BNP Product Usage: VIDAS NTproBNP (PBNP) is an automated quantitative test for use on the instruments of th Event 73989 | Device | Class III | 1 |
Official channels
- FDA enforcement report Z-0841-2014The 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 66931. https://recallregister.com/fda/ii/66931/. 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:
Worldwide Distribution - USA (nationwide) and Internationally to U.S. Nationwide; Algerie, Argentina, Armenia, Australia, Austria, Azerbaidjian, Bahrain, Bangladesh, Belarus, Belgium, Benin,…
- What quantity of product is in FDA event 66931?
- The event has 3 product records. The first record gives this quantity:
39439 kits (includes ZYM B reagents, API Listeria * API NH kits)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 90% of the 1,236 device events that started in 2013 are in Class II.