| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00604-1 |
| Product Name/Description |
VITROS Immunodiagnostic Products. An in vitro diagnostic medical device (IVD).
VITROS Immunodiagnostic Products Folate Reagent Pack 1/2
Product Code: 1513266 (10758750009237)
VITROS Immunodiagnostic Products Vitamin B12/Folate Reagent Pack 3
Product Code: 1142561 (10758750008476)
VITROS Immunodiagnostic Products Red Cell Folate Pack
Product Code: 1107804 (10758750008407)
ARTG 200533
(Ortho-Clinical Diagnostics Australia Pty Ltd - Clinical chemistry vitamin and mineral IVDs) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
18/07/2024 |
| Responsible Entity |
|
| Reason/Issue |
QuidelOrtho investigated customer complaints regarding generation of condition code “TM5-4MA” or “TM5-4MB” when testing the VITROS Folate on VITROS 3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems.
It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon addition of folate stabiliser reagent as part of the pre-treatment process which takes place in the MicroWell incubator middle ring.
Plasma from patients with elevated fibrinogen levels may be predisposed to causing “TM5-4MA” or “TM5-4MB” condition codes. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are to do the following:
· If retesting the sample leads to subsequent “TM5-4MA” or “TM5-4MB” condition codes, it may not be possible to generate a result with this sample on the VITROS 3600 Immunodiagnostic Systems or VITROS 5600/XT 7600 Integrated Systems.
· Use serum samples instead of plasma if repeat “TM5-4MA” or “TM5-4MB” condition codes are noted with a particular patient plasma sample. |
| Contact Information |
1800 032 359 - Technical Services Center |