Recall Z-0296-2014— Ortho-Clinical Diagnostics

Name: FDA recall Z-0296-2014
Creator: U.S. Food and Drug Administration
Published: 2013-06-12

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2013-06-12, terminated 2017-04-11. It names 2 FDA 510(k) clearances: K922072, K833833. Product: VITROS Chemistry Products ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.. Reason: Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues..

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2013-06-12
Terminated: 2017-04-11
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

2 on FDA's record

K922072 — KODAK EKTACHEM 250 ANALYEREastman Kodak Company·cleared 1992-07-10
K833833 — KODAK EKTACHEM 700 ANALYZEREastman Kodak Company·cleared 1984-01-17

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 ALKP Slides, 300 slides/pack; catalog number 1053180 VITROS ALKP Slides quantitatively measure alkaline phosphatase (ALKP) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Reason for recall

Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues.

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