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Acute Care™ D-DIMER CalPak
Siemens Healthcare Diagnostics Inc. · Model 10445076 · UDI-DI 00842768004575
1
510(k) clearances
227
Adverse events (3 deaths)
13
Recalls
29
Facilities
Description
The Stratus® CS Acute Care™ DDMR Calibrator (DDMR CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ DDMR method
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-05 | Diagnostica Stago, Inc. | After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-09-12 | Diagnostica Stago, Inc. | A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2013-04-17 | BioMerieux SA | Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negatives are being reported for results around the medical decision point |
| 2012-06-07 | Siemens Healthcare Diagnostics, Inc. | Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (instrument errors), wh |
| 2012-05-22 | Alere San Diego, Inc. | Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or f |
| 2006-04-03 | Dade Behring , Inc. | Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Te |
| 2006-04-03 | Dade Behring , Inc. | Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Tes |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.