| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01599-1 |
| Product Name/Description |
Reagent Red Blood Cells 0.8% Resolve Panel C. An in vitro diagnostic medical device (IVD).
Product Code: 6902319
Lot Number: VRC226
Expiry: 3 January 2017
ARTG Number: 254792 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics (Ortho) has received an increase in customer complaints and has confirmed the intermittent presence of marked haemolysis in Ortho Reagent Red Blood Cell (RRBC) products as well as Quality Control products containing red blood cells. Ortho conducted an extensive investigation, and the root cause for the marked haemolysis, has been identified as microbial contamination. There is a single lot of one product affected in Australia, Reagent Red Blood Cells 0.8% Resolve Panel C.
If markedly haemolysed red cell products are used in testing, erroneous (false positive or false negative) results may be generated, which can potentially lead to patient harm. To date, Ortho has received no reports of erroneous patient/donor results due to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
OCD is advising users to visually inspect all products prior to use and, as per the instructions for use, do not use red cell products if marked haemolysis or evidence of contamination is observed. If the product has marked haemolysis, contact Ortho Care Technical Solutions Center to report the issue so that the product can be replaced or credited. This action has been closed-out on 26/05/2017. |
| Contact Information |
1800 032 359 - Ortho Care Technical Solutions Centre |