Ortho-Clinical Diagnostics: Medical Device Recall in 2012 - (Recall #: Z-2211-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 28, 2012

Date Posted: August 22, 2012

Recall Number: Z-2211-2012

Event ID: 62612

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

Status: Terminated

Product Quantity: 13338 sale units

Code Information:

Lots from coating 0204, 0205, 0206. A Coating (CTG) is a unique identifier within the Lot Number of some of OCDs products

Distribution Pattern:

Worldwide Distribution - US (nationwide)

Voluntary or Mandated:

Voluntary: Firm initiated