Recall Z-2804-2016
Ortho-Clinical Diagnostics · initiated April 19, 2016
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
The VITROS Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the determination of percent glycated hemoglobin (HbA1c) in human whole blood.
Codes / lots: Lot 3155 Product Codes: 6842906 & 6801876
Reason for recall
There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay.
FDA-determined cause: Employee error
Action taken
On 19 April 2016, Ortho Clinical Diagnostics distributed Correction Notification letters (Ref. CL2016-087) and ADD DRV 5877 notices to their US consignees via courier service and to their foreign affiliates via email. Customers were advised to install the Assay Data Diskette DRV 5877 or above on their VITROS system. Following a successful calibration and quality control assessment, it is acceptable to use VITROS HbA1c Reagent Kit, GEN 06. Customers who further distributed the product should also provide a copy of the enclosed letter to all customers who received the product. It is suggested that customers complete and return the Confirmation of Receipt form to indicate that you have been informed of this issue. Customers with questions can contact the Technical Solutions Center at 1-800-421-3311.
Details
- Recall number
- Z-2804-2016
- Initiated
- April 19, 2016
- Terminated
- June 8, 2018
- Product code
- JIT – Calibrator, Secondary
- Quantity
- 520 Units
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CT, DC, FL, GA, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OK, OR, PA, SC, TN, TX, WA, WV & Puerto Rico;** Foreign: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy & Spain.
- Recalling firm
- Ortho-Clinical Diagnostics, Rochester, NY