Z-2211-2012Class II

VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides...

Name: Z-2211-2012 VITROS Chemistry Products DGXN Slides --- [REF] 834 3386. Product is packaged in a box with multiple slides...
Creator: Ortho-Clinical Diagnostics
Published: 2012-06-28
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2012-06-28 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of 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... on 2012-06-28. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2211-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-28
Posted: 2012-08-15
Terminated: 2016-05-20
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: LFM Enzyme Immunoassay, Digitoxin
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ortho Clinical Diagnostics sent an Urgent Field Safety Notice dated June 28, 2012, via US Postal Service Priority Mail to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: Immediately discontinue using heparin plasma samples and use only serum samples when processing VITROS DGXN Slides; Notify their laboratory and medical staff of this change and forward the information if the product have been distributed outside of your facility; Replace the pages of their VITROS Instructions for Use Manual with the enclosed Instructions for Use and Table of Contents; and Discontinue using any copies of the VITROS DGXN Slide IFU (Version 7.0).--- On 28 June 2012 an Urgent Field Safety Notice was sent via US Postal Service Priority Mail to all affected Distributors. They were advised of the issue and instructed to discontinue distributing and discard their remaining inventory of VITROS DGXN Slides. --- Foreign affiliates were informed by email on 28 June 2012 of the issue and instructed to notify their consignees of the issue and actions. The letters included a Confirmation of Receipt form to be completed and return. For questions contact Customer Technical Servives at 1-800-421-3311
Quantity in commerce: 13338 sale units
Distribution: Worldwide Distribution - US (nationwide)
Product codes and lots: Lots from coating 0204, 0205, 0206. A Coating (CTG) is a unique identifier within the Lot Number of some of OCDs products

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2211-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2211-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-22	2012-08-15

Product code LFM

K942610Class IIKodak Extachem Clinical Chemistry Slide Digoxin (Dgxn)Eastman Kodak Company / cleared 1994-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)