Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
Recall
- Recall Number
- Z-2012-2012
- Event Number
- 62281
- Firm
- Critical Diagnostics
- FEI Number
- 3008661376
- Product Code
- OYG
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- February 28, 2012
- Posted
- July 13, 2012
- Terminated
- July 16, 2012
- Address
- 3030 Bunker Hill St, Ste 115a, San Diego, CA, 92109-5754
Description
Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits.
Critical Diagnostics sent a Medical Device Recall letter dated March 5, 2012, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customer. Customers were instructed to please use Federal Express (FedEx) to return the kits, and charge to account: 305599069 Replacement kits will be sent to you. Customers with questions about this notice were instructed to contact Critical Diagnostics' customer support at (877) 700-1250 ext 3.
USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
33 units