| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00957-1 |
| Product Name/Description |
PreciControl ClinChem Multi 1 Lot No. 174787 & 174794
PreciControl ClinChem Multi 2 Lot No. 174801 & 174801
(Potentially all lots are affected; this issue is easily detected as the QC will be elevated. Patient samples are not affected.)
ARTG number: 216332 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
25/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Roche has received a number of complaints that the recovery of C-Reactive Protein Gen. 3 (CRPL3) was too high in PreciControl ClinChem Multi 1 (PCCC1), and especially in PreciControl ClinChem Multi 2 (PCCC2), seen mainly on the cobas c 501 module.
Roche Diagnostics has investigated and determined that the last three reagent lots showed higher recovery for all control materials. To resolve this issue a revised target value assignment procedure was necessary.
Target values for currently available PCCC1 and PCCC2 control lots have been adjusted – as per the tables given in the Customer Letter. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Target values for currently available PCCC1 and PCCC2 control lots have been adjusted – as per the tables given in the Customer Letter. Users are requested to use these revised values. This action has been closed-out on 04/03/2016. |
| Contact Information |
02 9860 2357 - Roche Diagnostics |