| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00367-1 |
| Product Name/Description |
VITROS Immunodiagnostic Products CK-MB Calibrators. An in vitro diagnostic medical device (IVD)
Product Code: 1286293 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
23/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
Ortho Clinical Diagnostics has revised the storage instructions for VITROS Immunodiagnostic Products CK-MB Calibrators. Internal testing demonstrated that opened-reconstituted VITROS CK-MB Calibrators stored at -20degC generated invalid calibrations that were detected by positively biased quality control results. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
OCD is updating the instructions for use to reflect that refrigerated storage at 2-8 degrees centigrade is acceptable. OCD is asking users to discontinue use of units stored at -20 degrees centigrade. This action has been closed-out on 11/02/2016. |
| Contact Information |
1800 032 0359 - Ortho-Clinical Diagnostics Customer Technical Services |