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Stratus® CS Acute Care™ DDMR DilPak
Siemens Healthcare Diagnostics Inc. · Model 10445077 · UDI-DI 00842768004582
1
510(k) clearances
227
Adverse events (3 deaths)
13
Recalls
29
Facilities
Description
The Stratus® CS Acute Care(TM) D-dimer Dilution Pak (DDMR DilPak) is an in vitro diagnostic product intended to be used in conjunction with the Acute Care(TM) DDMR TestPak for the measurement of samples with elevated levels of D-dimer.
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.