FDAFDA · Food and drugs·Recall number Z-2012-2012
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.
Published July 25, 2012 · Recall initiated: February 28, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Critical Diagnostics
- Distributor
- USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
- Lot
- 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.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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