| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00502-1 |
| Product Name/Description |
VITROS ALT, ALKP, AST, CHE, CK, GGT and LDH results generated on VITROS 4600 Chemistry System, VITROS 5600 Integrated System and VITROS 5,1 FS Chemistry System
VITROS 4600 Chemistry System
Product Code: 6802445
Affected Software Versions: 3.0 and lower
VITROS 5600 Integrated System
Product Code: 6802413
Affected Software Versions: 3.0 and lower
VITROS 5,1 FS Chemistry System
Product Codes: 6801375, 6801890
Affected Software Versions: 2.7 and lower
Multiple assays affected |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
This recall action has been initiated by Ortho-Clinical Diagnostics, Inc. (OCD) due to the potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS® Systems listed. A MW code is a flag/error code generated when a potential issue with the results calculation is detected. This code does not suppress the sample result. A MW code is a flag/error code generated when a potential issue with the results calculation is detected. This code does not suppress the sample result. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho-Clinical Diagnostics (OCD) will resolve this issue in a future software release. To assist in the interim OCD is providing a procedure for reviewing VITROS chemistry results and MW codes. This action has been closed-out on 11/02/2016. |
| Contact Information |
1800 032 359 - Ortho-Clinical Diagnostics Customer Technical Services |