Recall Z-1071-2016— Ortho-Clinical Diagnostics

Name: FDA recall Z-1071-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-21

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2015-12-21, terminated 2018-05-30. It names one FDA 510(k) clearance: K922072. Product: VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.. Reason: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall)..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2015-12-21
Terminated: 2018-05-30
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K922072 — KODAK EKTACHEM 250 ANALYEREastman Kodak Company·cleared 1992-07-10

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 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR) tests using multi-layered VITROS Slides.

Reason for recall

Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1 FS, 4600 and 5600 Chemistry Systems when using Calibrator Kit 9, Lot 954. A trend of complaints regarding customers actions following U90-382 or 6LU condition codes was noted (See RES 72289 - VITROS Calibrator Kit 9, lot 954 recall).

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