Recall Z-1490-2014 ยท JFY Enzymatic Method, Creatinine
Ortho-Clinical Diagnostics
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.
| Date | Apr 23, 2014 (initiated Jan 29, 2014) |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071216 | VITROS CHEMISTRY PRODUCTS CRSC SLIDES, VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL 680 2721, 195 7927 Ortho-Clinical Diagnostics, Inc., May 25, 2007 |