Z-0843-2014Class II

API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and...

Name: Z-0843-2014 API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and...
Creator: Biomerieux France Chemin De L'Or
Published: 2013-11-08
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2013-11-08 / Terminated

FDA source

Biomerieux France Chemin De L'Or began a recall of API NH (REF 10400) API NH is a standardized system for the identification of Neisseria, Haemophilus (and related genera) and Moraxella catharrhalis... on 2013-11-08. FDA classified it as Class II and gives the reason as "bioMrieux 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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0843-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-08
Posted: 2014-01-27
Terminated: 2017-11-30
Recalling firm: bioMerieux, Inc.
Product: 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 Haemophilus parainfluenxzae, as well as the detection of a penicllinase.
Reason for recall: bioMrieux 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.
FDA root cause: Under Investigation by firm
Action: bioMerieux sent an Urgent Product Removal Notice letter dated November 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure the letter and guidance were distributed and received by all appropriate personnel in their organization, customers were instructed to discontinue use and destroy ZYM (B 70493), API NH (10400) API Listeria (10300) with ZYM B ampules having a visual defect. Customers still in possession of some kits of ZYM B (70493-Lots: 1) without visual defect that is used with API 20 Strep (20600), API Coryne (20900), API Staph (20500) and API ZYM (25200), have the option to: a) Use the kits of ZYM B (70493) still in your inventory with the following mandatory requirement for the API Strep and API Coryne: perform a daily quality control with the ATCC strain described in the paragraph Reading and Interpretation of the package insert of each API strip prior to using the ZYM B ampules. b) Use the kits of ZYM B (70493) still in your inventory without any requirement with API Staph and API ZYM, or c) Discard all kits of ZYM B (70493) still in their inventory. If you are still in possession of some kits of API NH (10400-Lots: See Annex 1) without visual defect of ZYM B, you have the option to: a) Use the kits of API NH (10400) still in your inventory with the mandatory requirement: perform a daily quality control with the ATCC strain 49917 Haemophilus paraphrophilus described in the paragraph Use of the reagents of the package insert of API NH prior to using the ZYM B ampules or, b) Discard all the kits of API NH (10400) still in your inventory. 5. If you are still in possession of some kits of API Listeria (10300-Lots: See Annex 1) without visual defect of ZYM B, we ask you to use the API Listeria (10300) still in your inventory with the mandatory requirement: perform a daily quality control with the ATCC strain 33090 Listeria innocua as
Quantity in commerce: 39439 kits (includes ZYM B reagents, API Listeria * API NH kits)
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to U.S. Nationwide; Algerie, Argentina, Armenia, Australia, Austria, Azerbaidjian, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Chad, Chile, China, Colombia, Democratic Republic of Congo, Costa Rica, Cote d'Ivorie, Germany, Czech Republic, Dominican Republic, Dutch Antilles, Dutch Antilles, Ecuador, Egypt, Republica De El Salvador, Estonia, Germany, Ethiopia, France, Gabon, Georgia, Germany, Greece, Guatemala, Guinea, Herzegovina, Honduras, Hungary, India, Germany, Indonesia, Iraq, Israel, Italy, Jamaica, Japan, Iraq, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malaysia, Malaysia, Mali, Malta, Mexico, Romania, Mongolia, Morocco, Mozambique, Singapore, Netherlands, Managua, Niamey Niger, Nigeria, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Uganda, Kingdom of Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Tanzania, Italy, Thailand, Trinidad & Tobago, Tunisia, Turkey, Uganda, Ukraine, UAE, United Kingdom, Uruguay, Venezuela, Vietnam, Vietnam, Yemen and Zimbabwe
Product codes and lots: Lot numbers: 1001896203, 1001957530, 1001957531, 1002112170, 1002112171, 1002112172, 1002279351, 1002340500, 1002112173, 1002171111, 1002171110, 1002279350, 1002279352, 1002340501, 1002340502, 1002340503, 1002412550, 1002412551, 1002485910, 1002485911, 1002455912.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0843-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0841-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27
Z-0842-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27
Z-0843-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-05	2014-01-27

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)