Recall Z-1736-2014— Ortho-Clinical Diagnostics

Name: FDA recall Z-1736-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-10

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2014-04-10, terminated 2018-05-21. It names 2 FDA 510(k) clearances: K063144, K031924. Product: VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.. Reason: Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected.

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2014-04-10
Terminated: 2018-05-21
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 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.

Reason for recall

Potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System and the VITROS 5,1 Chemistry System. MW codes may be associated with results from any of the following VITROS Chemistry Products using multiple point (multipoint) rate measurements. The MicroSlide assays that could be affected

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