| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01090-1 |
| Product Name/Description |
VITROS Immunodiagnostic Products Signal Reagent. An in vitro diagnostic medical device (IVD)
Product Code: 1072693
Lot Numbers: 4492 and above
Expiry: 13 Aug 2017 and later (as until this issue is resolved, future lots may be affected)
ARTG: 180199 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics (OCD) updated the reagent pack (i.e. bottle) for VITROS Signal Reagent, beginning with Lot 4492. Some customers have reported that their VITROS 3600 or 5600 System cannot detect the presence of the VITROS Signal Reagent pack when using Lot 4492 or above.
An investigation by OCD determined that sensors on the VITROS System may not detect the base of the updated VITROS Signal Reagent Packs due to a larger indentation at the base of the reagent pack. As a result, some VITROS 3600 or 5600 Systems may not be able to continually detect VITROS Signal Reagent Packs in the load positions or during testing at the in-use position.
If the sensor cannot detect the base of the pack, that pack cannot be used to process samples. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
If the VITROS 3600 or 5600 System cannot detect the presence of VITROS Signal Reagent Packs, users are to contact the Ortho Care Technical Solutions Centre for immediate assistance. An Ortho trained service representative will schedule the installation of MOD C3.
Complete the Confirmation of Receipt form supplied with customer letter and if the affected lots were distributed to a different location, please forward the notification on.
This action has been closed out on 18/02/2019 |
| Contact Information |
1800 032 359 - Ortho Care Technical Solutions Centre |