AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic recall
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative…
Why was AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic recalled?
Kits incompatible with certain fluorescence microscope light sources
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?
Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B
- Product
- AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative…
- Recalling firm
- AdvanDx, Inc.
- Quantity
- 49 kits US; 17 kits OUS
- Distribution
- Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.
- Recall date
- January 8, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)