—#125634

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.

FDA product code: JFY — Enzymatic Method, Creatinine
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K071216
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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: ConfirmationAdmin@its.jnj.com. 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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 1000 Lee Road, Rochester, New York 14606

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2014-01-29
Posted by FDA: 2014-04-23
Terminated: 2018-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125634. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.