—#145890

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.

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K142595
Affected lot / code info: Lot 3155 Product Codes: 6842906 & 6801876

Why it was recalled

There is an incorrect value (data/calibration mathematics) on ADDs. This incorrect value will prevent a successful calibration of the assay.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 1000 Lee Road, Rochester, New York 14606

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-04-19
Terminated: 2018-06-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #145890. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.