| Class 3 Device Recall VITROS Chemistry Products Calibrator Kit 31 | |
Date Initiated by Firm | April 19, 2016 |
Create Date | September 15, 2016 |
Recall Status1 |
Terminated 3 on June 08, 2018 |
Recall Number | Z-2804-2016 |
Recall Event ID |
74009 |
510(K)Number | K142595 |
Product Classification |
Calibrator, secondary - Product Code JIT
|
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. |
Code Information |
Lot 3155 Product Codes: 6842906 & 6801876 |
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics 1000 Lee Road Rochester NY 14606
|
For Additional Information Contact | Ms. Jennifer Paine 908-218-8776 |
Manufacturer 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 2 | Employee error |
Action | 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. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = JIT
|
|
|
|