FB Reagent recall
FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and…
Why was FB Reagent recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Codes - 1002717180, Exp. Date 5/30/2014, 1002737220, Exp. Date 6/13/2014, 1002778550, Exp. Date 8/9/2014, 1002782960, Exp. Date 8/15/2014, 1002792840, Exp. Date 8/15/2014, 1002834130, Exp. Date 8/22/2014, 1002877370, Exp. Date 8/22/2014
- Product
- FB Reagent (REF 70562). FB reagent is an additional test used for revealing the results of some miniaturized biochemical test included in the API and…
- Recalling firm
- BioMerieux SA
- Quantity
- 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.
- Recall date
- April 30, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)