Recall Z-1364-2019— Ortho-Clinical Diagnostics

Name: FDA recall Z-1364-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-20

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2019-03-20, terminated 2020-12-08. It names one FDA 510(k) clearance: K182063. Product: VITROS XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest. Reason: Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported.

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2019-03-20
Terminated: 2020-12-08
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc.·cleared 2018-10-30

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 XT 7600 Integrated System, with V3.4 or 3.4.1 SW Product Code: 6844461 Product Usage: INTENDED USE: For in vitro diagnostic use only. The VITROS XT 7600 Integrated System is intended for use in the measurement of a variety of analytes of clinical interest

Reason for recall

Potential for sample fluid to be dispensed to an incorrect position on the MicroSlide, potentially leading to erroneous assay results being reported

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