Z-2214-2014Class II

VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are...

Name: Z-2214-2014 VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are...
Creator: Ortho-Clinical Diagnostics
Published: 2014-07-15
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-07-15 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products... on 2014-07-15. FDA classified it as Class II and gives the reason as "Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems". 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-2214-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-15
Posted: 2014-08-13
Terminated: 2018-05-21
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY
Product code: JIX Calibrator, Multi-Analyte Mixture
Reason for recall: Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ortho Clinical Diagnostics sent an Urgent Product Correction Notification letter dated July 15, 2014,by Federal Express overnight to all affected customers. All US end-user consignees who had been shipped VITROS NH3 DT slides, GEN 59, Product Code 1532589 were informed of the issue. Customers were instructed to: a) use VITROS DT NH3 slides, GEN 59 with Calibration Data Module, Rev. 0168 or 0169 with VITROS DT Calibrator, Lot 42 if available; or b) If VITROS DT Calibrator, lot 42 is not available, the user is instructed to request CDM, Rev. 0170 to be used with VITROS NH3 DT slides, GEN 59 and VITROS DT Calibrator, Lot 44. Customers were instructed to forward this notice if the product was further distributed outside of their facility. OCD has manufactured a new CDM, Rev. 170, containing the necessary data/calibration mathematics for VITROS DT Calibrator, Lot 44 to be used to calibrate VITROS NH3 DT slides, GEN 59. Customers with questions were instructed to call Customers Technical Services at 1-800-421-3311. For questions regarding this recall call 908-218-8776.
Quantity in commerce: 5906 total: 240 (US); 5666 (OUS)
Distribution: Worldwide Distribution - USA including MA, TX, KY, IL, MS, OH and Puerto Rico; Internationally to: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
Product codes and lots: Lots 0168 and 0169

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2214-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2214-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-20	2014-08-14

Product code JIX

K072443Class IIVitros Chemistry Products Ca Dt Slides and Dt Calibrator Kit and Vitros Ca AssayOrtho-Clinical Diagnostics, Inc. / cleared 2007-09-24

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)