Optilite C-Reactive Protein Kit - Product Usage: The recall
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of…
Why was Optilite C-Reactive Protein Kit - Product Usage: The recalled?
Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
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?
Model Number: NK044.OPT.A Lot 437705 UDI 05051700018449 Medical Device Listing number D317086
- Product
- Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of…
- Recalling firm
- The Binding Site Group, Ltd.
- Quantity
- 10 kits
- Distribution
- US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS
- Recall date
- December 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)