DeviceClearance

Recall Z-0202-2016— Ortho-Clinical Diagnostics

Class III · Terminated

Class III FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2015-09-28, terminated 2018-05-22. It names 2 FDA 510(k) clearances: K081543, K941142. Product: VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.. Reason: The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954..

Recalling firm
Ortho-Clinical Diagnostics
Classification
Class III
Status
Terminated
Initiated
2015-09-28
Terminated
2018-05-22
Firm location
Rochester, NY, United States

510(k) clearances named in this recall

2 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VITROS Chemistry Products Calibrator Kit 9 Calibrator, 2 mL, Product Code 8568040, Unique Device Identifier No. 10758750005031, IVD -- Ortho Clinical Diagnostics, Inc. --- VITROS Chemistry Products Calibrator Kit 9 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of ACET, CRBM, DGXN, and PHYT.

Reason for recall

The firm is conducting a product correction due to an increase in U90-382 or 6LU condition codes (wash errors) when using VITROS Calibrator Kit 9, Lot 0954.

Data sourced from openFDA. This site is unofficial and independent of the FDA.