Recall Z-2119-2016
Ortho-Clinical Diagnostics · initiated May 24, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
Codes / lots: Lots 2915 (exp. December 2016) and 1995 (exp. July 2016)
Reason for recall
Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.
FDA-determined cause: Nonconforming Material/Component
Action taken
Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated May 24, 2016, via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Drop-Ship and US Federal Government) to inform them of the issue and advised them to discontinue using the affected product until Assay Data Diskette (ADD) Data Realease Version (DRV) 5884 or above was installed on their VITROS System. Foreign affiliates were informed of the issue via e-mail on 5/24/2016 and instructed to notify their consignees of the issue and required actions. Customers with questions were advised to contact Ortho's Customer Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
Details
- Recall number
- Z-2119-2016
- Initiated
- May 24, 2016
- Terminated
- June 8, 2018
- Product code
- JMO – Ferrozine (Colorimetric) Iron Binding Capacity
- Quantity
- US: 1517; Foreign: 842
- Distribution
- Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, and Venezuela.
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY