Z-2012-2012 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2012
- Initiation Date
- February 28, 2012
- Termination Date
- July 16, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33 units
Product 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.
Reason for Recall
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.
Distribution Pattern
USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
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.