Device product
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.
Z-2012-2012
Product summary
- Event
- Event 62281
- Status
- Terminated
- Classification
- Class III
- Quantity
- 33 units
- Official record key
device-enforcement:Z-2012-2012
Official wording
Reason: 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.
Code information: BC-1065 (US distribution) Lot No. RN-43116-4 BC-1065 E (European Distribution) Lot No. RN-42467-1, RN-42467-2, RN-43116-1, RN-43116-2, RN-43116-3.
Distribution pattern: USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
Derived failure modes
-
Unknown
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.