Recall Z-0059-2019 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
Ortho Clinical Diagnostics Inc
VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922
| Date | Jul 12, 2018 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| Action | On 12 July 2018, a customer letter was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail to all customers who could process the affected products (i.e., VITROS 3600, 5600 and/or ECi/ECiQ Systems) to inform them of the potential interference of biotin at levels lower than stated in the IFUs and that Ortho is in the process of revising the IFUs for the affected products. Ortho recommended customers follow normal laboratory procedures for troubleshooting of samples containing other assay interferences and it was acceptable to continue u |
| Quantity | 1955 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964720 | VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) Johnson & Johnson Clinical Diagnostics, Inc., Feb 4, 1997 |