Z-1490-2014Class II

VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in...

Name: Z-1490-2014 VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in...
Creator: Ortho-Clinical Diagnostics
Published: 2014-01-29
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-01-29 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT... on 2014-01-29. FDA classified it as Class II and gives the reason as "Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code...". 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-1490-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-29
Posted: 2014-04-23
Terminated: 2018-05-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products CDM PROM (Calibration Data Module) No. 0168, Catalog Number/REF 199 9077, used in conjunction with: VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, REF 6802721, and VITROS DT Calibrator Kit, Product Code 1957924, and tested on the VITROS DT60/DT60 II Chemistry System; IVD --- Ortho-Clinical Diagnostics, Inc.
Product code: JFY Enzymatic Method, Creatinine
Reason for recall: Customers were unable to calibrate, or use previously calibrated, VITROS DT CRSC slides (REF/Product Code 6802721), GEN 82, on the VITROS DT II System, when using Calibration Data Module (CDM) Rev. 168 (REF/Product Code 199 9077), as CDM 168 does not contain calibration parameters for DT CRSC.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ortho Clinical Diagnostics sent an Urgent Product Correction Notification Letters dated January 29, 2014, via FedEx overnight courier and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees to inform them of the issue. Customers were advised to Inspect their inventory to determine if they had VITROS CRSC DT Slides, GEN 82. - To use their current inventory of GEN 82 until the replacement order arrives providing that they have CDM PROM 0167 installed on their system and calibrate using VITROS DT Calibrator Kit, Lot 42. - If product replacement is required, discard their remaining inventory of VITROS CRSC DT Slides, GEN 82 upon receipt of their replacement order. - Complete and return the Confirmation of Receipt Form by February 7, 2014, by fax to 1-888-557-3759 or 1-585-453-04110, or email to: [email protected]. Indicate on the form if they have any inventory of the affected lot that will require replacement. - Forward this information if they have distributed this product outside of your facility. Distributors were also instructed to identify all customers and any other branches who were shipped VITROS CRSC DT Slides, GEN 82 from their facility and send a copy of the Urgent Product Correction Notification Letter to inform them of the issue. Foreign affiliates were informed by e-mail on January 22, 2014, of the issue and instructed to notify their consignees of the issue and required actions.
Quantity in commerce: US: 284 units, Ex-US: 4772 units
Distribution: Worldwide Distribution - US Distribution including the states of AR, FL, IA, IL, KY, MI, MN, ND, NY and VA, and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
Product codes and lots: Calibration Data Module Rev. 0168, REF 199 9077 used in conjuction with of VITROS Chemistry Products CRSC DT Slides, Generation (GEN) 82, Product Code 6802721.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1490-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1490-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-23

Product code JFY

K071216Class IIVitros Chemistry Products Crsc Slides, Vitros Chemistry Products Dt Calibrator Kit, Model 680 2721, 195 7927Ortho-Clinical Diagnostics, Inc. / cleared 2007-05-25

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)