Recall Z-0060-2019
Ortho Clinical Diagnostics Inc · initiated July 12, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
Codes / lots: 2330 2340 2350 2360 2370 2380
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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 using the affected products. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Details
- Recall number
- Z-0060-2019
- Initiated
- July 12, 2018
- Product code
- CFT – Radioimmunoassay, Prolactin (Lactogen)
- 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.
- Recalling firm
- Ortho Clinical Diagnostics Inc, Raritan, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0058-2019 Class II | VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products… | 07/12/2018Open, Classified |
| Z-0059-2019 Class II | VITROS Immunodiagnostic Products - FSH Reagent Pack (10758750000302) 1931922The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products… | 07/12/2018Open, Classified |
| Z-0061-2019 Class II | VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products… | 07/12/2018Open, Classified |