VITROS Immunodiagnostic Products Total T4 Reagent Pack recall
VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical…
Why was VITROS Immunodiagnostic Products Total T4 Reagent Pack recalled?
Ortho-Clinical Diagnostics confirmed that sample results generated from VITROS Immunodiagnostic Products Total T4 Reagent Packs may show a negative bias prior to the open pack storage limit of <= 8 weeks that is located in the Instructions for Use (IFU) for VITROS Immunodiagnostic Products Total T4 Reagent Pack.
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 Numbers:1836, 1840, 1845, 1850, 1860, 1870, 1880, 1890, 1900, 1910, 1920, 1930, 1940, 1950, 1968, 1978, 1988, 1998
- Product
- VITROS Immunodiagnostic Products Total T4 Reagent Pack, REF/Product Code 874 4468, Unique Identifier No. 10758750005147, IVD --- Ortho-Clinical…
- Recalling firm
- ORTHO-CLINICAL DIAGNOSTICS
- Quantity
- US: 12,015; Foreign: 55 Sales Units to Canada, 223 Sales Units shipped to Bermuda
- Distribution
- Worldwide Distribution - US (Nationwide including Puerto Rico) and foreign distribution to Canada and Bermuda
- Recall date
- August 10, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)