VITROS Immunodiagnostic Products - Prolactin Reagent recall
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
Why was VITROS Immunodiagnostic Products - Prolactin Reagent recalled?
The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.
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?
2330 2340 2350 2360 2370 2380
- Product
- VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
- Recalling firm
- Ortho Clinical Diagnostics Inc
- Quantity
- 1790
- Distribution
- Worldwide Distribution - US Nationwide distribution, and countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, and Netherlands.
- Recall date
- October 10, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)