Recall Z-2211-2012— Ortho-Clinical Diagnostics

Name: FDA recall Z-2211-2012
Creator: U.S. Food and Drug Administration
Published: 2012-06-28

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2012-06-28, terminated 2016-05-20. It names one FDA 510(k) clearance: K942610. Product: VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration 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 revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen type for VITROS DGXN Slides.

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2012-06-28
Terminated: 2016-05-20
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K942610 — KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN)Eastman Kodak Company·cleared 1994-10-20

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 DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides. The lot and expiration codes are found on the side of the package. Product Usage: Intended use: For in vitro diagnostic use only. VITROS Chemistry Products DGXN Slides quantitatively measure digoxin (DGXN) concentration 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 revised the VITROS Chemistry Products DGXN Slides Instructions for Use (IFU) and removed heparin plasma as a recommended specimen type for VITROS DGXN Slides

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