| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01257-1 |
| Product Name/Description |
Calibration Diskette and Assay Data Disks used with VITROS chemistry instruments. An in vitro diagnostic medical device (IVD)
VITROS Chemistry Instruments:
-VITROS 4600
-VITROS 5600
-VITROS 250
-VITROS 350
-VITROS 5,1 FS
-enGen system
VITROS Chemistry Products:
ALT slides -1655281
CK slides -8479396, -8478034
LDH slides -8384489
hsCRP reagent -6801739
THC reagent -6801994
TIBC kit -8867541
METD reagent -6801996
CRBM slides -8892382 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
Ortho-Clinical Diagnostics, Inc. (OCD) has determined that the default dilution factors on the Calibration Diskette (Cal Disk) and Assay Data Disks (ADD), DRV 5740 and below, are incorrect. It has also been determined that the 2nd dilution factors contained in the enGen Laboratory Automation System configuration (.gsb) file (Version 3.2.2 & Below) are incorrect. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho-Clincial Diagnostics is providing their customers with Local Cal Disk or ADD version 5741 which contains the correct dilution factors. Customers are also advised to review their LIS data to determine the impact of the revised default dilution factors. For those customers using the enGen system, an Ortho-Clinical Diagnostics representative will assist in the development of revised dilution factors. This action has been closed-out on 12/02/2016. |
| Contact Information |
1800 032 359 - Ortho-Clinical Diagnostics Customer Technical Service |