Critical Diagnostics: Medical Device Recall in 2012 - (Recall #: Z-2012-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: February 28, 2012

Date Posted: July 25, 2012

Recall Number: Z-2012-2012

Event ID: 62281

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.

Status: Terminated

Product Quantity: 33 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated