Z-1614-2013Class III

VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596

Name: Z-1614-2013 VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596
Creator: Ortho-Clinical Diagnostics
Published: 2013-05-09
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-05-09 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry... on 2013-05-09. FDA classified it as Class III and gives the reason as "While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process". 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-1614-2013
Classification: Class III
Status: Terminated
Initiated: 2013-05-09
Posted: 2013-06-27
Terminated: 2015-06-12
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products K+ (Potassium) Slides (Reagent), REF/Catalog Number 815 7596, Product Usage: For in vitro diagnostic use only. VITROS Chemistry Products K+ Slides quantitatively measure potassium (K+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: While performing interval testing, Ortho Clinical Diagnostics (OCD) determined that a surfactant was unintentionally added to VITROS Chemistry Products K+ Slides during the manufacturing process.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated May 9, 2013 via FedEx or US Priority Mail to all US customers. Foreign Affiliates were notified by e-mail on May 9, 2013 informing them of the issue. Distributors were instructed to notify their customers of the recall. Customers were instructed to discontinue use, discard the affected product, comp[lete and return the attached Confirmation of Recipt Form, and post this notification by each VITROS System. For questions call Customer Service Center at 1-800-828-6316.
Quantity in commerce: Domestic: 236,364; Foreign: 8,339
Distribution: Worldwide Disribution - USA Nationwide including Puerto Rico, and the countries of Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
Product codes and lots: GEN 4102, Coating 0884, Lot XXXX (exp. 06/01/2014) and GEN 4102, Coating 0885, Lot XXXX (exp. 06/01/2014 and 07/01/2014). The term GEN and Coating refer to specific segments of the reagent lot number.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1614-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1614-2013	Class III	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27
Z-1615-2013	Class III	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-27

Product code CEM

K083680Class IIVitros Chemistry Products K+dt Slides: Vitros Chemistry Products Dt Calibrator Kit, Model K+dt Slides: 153 2258Ortho-Clinical Diagnostics, Inc. / cleared 2009-02-27

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)