Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro d
FDA device recall Z-2012-2012 · posted 2012-07-13 · Terminated
Recall details
- Recalling firm
- Critical Diagnostics
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- OYG
- Quantity affected
- 33 units
- Distribution
- USA including the state of California and the countries of Austria, Spain, United Kingdom, and Italy.
- Date initiated
- 2012-02-28
- Date posted
- 2012-07-13
- Date terminated
- 2012-07-16
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PRESAGE ST2 ASSAY (K111452) | Critical Care Diagnostics, Inc. (Dba Critical Diag | 2011-12-09 |