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U.S. Department of Health and Human Services

Class 2 Device Recall API Listeria (REF 10300)

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 Class 2 Device Recall API Listeria (REF 10300)see related information
Date Initiated by FirmMarch 06, 2014
Date PostedApril 18, 2014
Recall Status1 Terminated 3 on March 14, 2017
Recall NumberZ-1478-2014
Recall Event ID 67820
Product Classification Device, general purpose, microbiology, diagnostic - Product Code LIB
ProductAPI Listeria (REF 10300). ZYM B reagent is used and included inside of API NH (REF 10400) and API Listeria (10300). All of the APIs are standardized systems combining several biochemical tests that enable group or species identification of most microorganisms.
Code Information Code - 1002569040, Exp. Date 8/29/2014, 1002569041, Exp. Date 8/296/2014, 1002587190, Exp. Date 9/3/2014, 1002856790, Exp. Date 7/18/2014, 1002856800, Exp. Date 6/12/2014
Recalling Firm/
Manufacturer		 BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
For Additional Information ContactRyan LeMelle
314-731-8582
Manufacturer 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 Determined
Cause 2		Other
ActionLetters 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 Commerce33,853
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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