| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00721-1 |
| Product Name/Description |
ORTHO BioVue System Cassettes (blood typing and compatibility tests). An in vitro diagnostic medical device (IVD).
Multiple products affected
ARTG Number: 31036
|
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics has identified isolated occurrences of improperly positioned cassette labels resulting in the barcode, lot number, expiration date and sequence number placed on the incorrect side of the cassette. The use of an affected multi-reagent cassette may lead to false negative or false positive results causing a potential misclassification of the patient or donor blood groups or incorrect antibody detection.
This issue potentially affects ABD Confirmation Cassettes, Rh/K Cassettes, Rh-hr Cassettes, ABO-DD Grouping Cassettes, ABO-Rh Grouping Cassettes and Anti-Human Globulin Neutral Solution (Poly/Neutral Cassettes). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho-Clinical Diagnostics (OCD) is requesting customers to discard any potentially affected lots. OCD is recommending discussion of previously reported patient results with the Laboratory Medical Director to determine the appropriate course of action. OCD can provide detailed information regarding the impact to previously reported results for each type of cassette. Please contact OCD for further information.
This action has been closed-out on 21/03/2018. |
| Contact Information |
1800 032 359 - Ortho Clinical Diagnostics Customer Technical Services |