Z-1477-2014Class II

API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria...

Name: Z-1477-2014 API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria...
Creator: BioMerieux SA
Published: 2014-03-06
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2014-03-06 / Terminated

FDA source

BioMerieux SA began a recall of API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems... on 2014-03-06. FDA classified it as Class II and gives the reason as "bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1477-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-06
Posted: 2014-04-18
Terminated: 2017-03-14
Recalling firm: bioMerieux, Inc.
Product: API NIH (REF 10400). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the API's are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
Product code: LIB Device, General Purpose, Microbiology, Diagnostic
Reason for recall: bioMerieux identified a visual defect and activity issue on the ZYM B reagent (REF 70493) and FB reagent (REF 70562). The activity issue lead to a false negative result of some Rapid ID 32 strips and API biochemical tests using the ZYM B reagent or FB reagent
FDA root cause: Other
Action: Letters were issued to customers on March 10, 2014. The letter contained instructions to be used if they still were using the product. The letter also included a report form which was to be returned.
Quantity in commerce: 33,853
Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico, and the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WV, WA, WI, and WY and the country of Algeria, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Benin, Bolivia, Bosnia, Brazil, Brunel, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Central African Republic, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Erythrea, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Haiti, Herzegovina, Honduras, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Jamaica, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mali, Mexico, Moldavia, Morocco, Mozambique, Myanmar, Netherlands, Nigeria, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Thailand, Trinidad & Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
Product codes and lots: Code - 1002786740, Exp. Date 6/3/2014, 1002809140, Exp. Date 6/18/2014, 1002814890, Exp. Date 9/9/2014, 1002814891, Exp. Date 9/9/2014, 1002826750, Exp. Date 6/3/2014, 1002869720, Exp. Date 6/18/2014, 1002869721, Exp. Date 12/13/2014, 1002485910, Exp. Date 6/3/2014, 1002485911, Exp. Date 6/18/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1477-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1475-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-18
Z-1476-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-18
Z-1477-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-18
Z-1478-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-18

Product code LIB

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