| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01008-1 |
| Product Name/Description |
VITROS Performance Verifier II. An in vitro diagnostic medical device (IVD)
Product Code (Unique Identifier): 8231474 (10758750004577)
Lot Number: K4852
Expiry: 22 Feb 2018 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
10/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics (Ortho) determined that the unopened storage condition for VITROS Performance Verifier II, Lot K4852 requires revision when using VITROS Chemistry Products AST Slides or VITROS Chemistry Products ASTJ Slides.
The Instructions for Use (IFU) states that unopened VITROS Performance Verifier II can be stored either frozen until the expiration date or refrigerated for =6 months. Stability testing determined that unopened vials for Lot K4852 did not meet the product’s 6 month specification when stored refrigerated. All other lots are not affected.
Product that is stored frozen is not affected by this issue. Customers can continue to use frozen-stored product through its expiration date. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Ortho Clinical Diagnostics is requesting customers:
1. Be aware that unopened vials of Lot K4852 can no longer be stored refrigerated to verify the performance of VITROS AST or ASTJ Slides;
2. Discard any remaining inventory stored refrigerated if used to verify VITROS AST or ASTJ Slides; and
2. Retain this notification as verification of the revised instructions.
Complete the Confirmation of Receipt form supplied with the customer letter and return by August 15th, 2017.
This action has been closed out on 01/11/2019 |
| Contact Information |
1800 032 359 - Ortho Clinical Diagnostic Technical Solutions Centre |