VITROS NT-proBNP Reagent recall
VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain…
Why was VITROS NT-proBNP Reagent recalled?
The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
All expired, in-date, and future lots released.
- Product
- VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain…
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Quantity
- 46598 total, 46062 units in US (100 tests per unit)
- Distribution
- Worldwide Distribution - US Nationwide domestic distribution. International distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, India, France, Japan, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
- Recall date
- January 9, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)