Recall Z-1226-2014 ยท CIG Diazo Colorimetry, Bilirubin
Ortho-Clinical Diagnostics
VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide i
| Date | Mar 19, 2014 (initiated Jan 9, 2014) |
| Status | Terminated |
| Reason | An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658. |
| Root cause | Error in labeling |
| Action | Ortho Clinical Diagnostics sent an Urgent Distributor Product Correction Notification letter dated January 9, 2014, via FedEx overnight courier to all affected customers. The letter notified users of the issue and the correct 460 nm value. Foreign affitliates were notified on January 9, 2014 via e-mail. The letter advised users to inspect their current inventory of VITROS White Correction Slides to determine if Lot 9052-0045-6358 is present. If there is remaining inventory of VITROS White correction Slides, Lot 9052-0045-6358, the remaining inventory may be discarded or the user may co |
| Quantity | 64 units worldwide |
| Distribution | Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain, and Venezuela. |
| FDA record | Open on fda.gov |