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Beckman Coulter, Inc. · Model ODC0029 · UDI-DI 15099590070588
GHH
Prescription
1
510(k) clearances
188
Adverse events (1 deaths)
9
Recalls
22
Facilities
Description
D-Dimer Control
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-03 | Roche Diagnostics Operations, Inc. | Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. |
| 2016-08-16 | Lsi Medience Corporation | Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product. |
| 2016-06-01 | BBI SOLUTIONS OEM LTD | A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Qualitative results may be affected. False negat |
| 2014-05-02 | Alere San Diego, Inc. | Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sam |
| 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 |
| 2011-06-13 | Tcoag Us, Incorporated | There is a performance issue with Minutex D-Dimer Kit which may cause false negative results for patient samples containing levels of greater than 250ng/mL D-Dimer. |
| 2007-02-15 | Inverness Medical Professional Diagnostics | Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off. |
| 2005-06-21 | Dade Behring , Inc. | positive control shows weak agglutination reaction |
| 2004-07-01 | Fisher Diagnostic, A Company of Fisher Scientific LLC | Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples. |
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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.