Z-2119-2016Class III

VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS...

Name: Z-2119-2016 VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS...
Creator: Ortho-Clinical Diagnostics
Published: 2016-05-24
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-05-24 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN... on 2016-05-24. FDA classified it as Class III and gives the reason as "Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to...". 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-2119-2016
Classification: Class III
Status: Terminated
Initiated: 2016-05-24
Posted: 2016-07-01
Terminated: 2018-06-08
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Calibrator Kit 29, REF/Product Code 680 2344, used in conjunction with VITROS Chemistry Products dTIBC Reagent Generation 30 (GEN 30), REF 680 2001, and Assay Data Disk (ADD), REF/Product Code 6801876 (Unique Device No. 10758750001576), Data Release Versions (DRVs) 5870 through 5883 inclusive; IVD --- Ortho-Clinical Diagnostics For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
Product code: JMO Ferrozine (Colorimetric) Iron Binding Capacity
Reason for recall: Ortho Clinical Diagnostics started receiving customer complaints for biased results when using VITROS dTIBC Reagent GEN 30 product. Ortho's investigation confirmed that incorrect calibration mathematics were assigned to the Calibrator Kit 29 Lots 2915 and 2995 supporting dTIBC Reagent GEN 30 product.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Ortho Clinical Diagnostics sent an Important Product Correction Notification letter dated May 24, 2016, via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (Ortho Direct, Drop-Ship and US Federal Government) to inform them of the issue and advised them to discontinue using the affected product until Assay Data Diskette (ADD) Data Realease Version (DRV) 5884 or above was installed on their VITROS System. Foreign affiliates were informed of the issue via e-mail on 5/24/2016 and instructed to notify their consignees of the issue and required actions. Customers with questions were advised to contact Ortho's Customer Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
Quantity in commerce: US: 1517; Foreign: 842
Distribution: Worldwide Distribution - US (Nationwide, Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, Poland, and Venezuela.
Product codes and lots: Lots 2915 (exp. December 2016) and 1995 (exp. July 2016)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2119-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2119-2016	Class III	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-01

Product code JMO

K052867Class IVitros Chemistry Products Dtibc ReagentOrtho-Clinical Diagnostics, Inc. / cleared 2005-12-23

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)