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iQ®200
IRIS INTERNATIONAL, INC. · Model iQ® Lamina™ Cradle · UDI-DI 10837461002192
LKM
Prescription
10
510(k) clearances
14
Adverse events
6
Recalls
12
Facilities
Description
iQ® Lamina™ Cradle
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-12-19 | Beckman Coulter, Inc. | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to ge |
| 2023-12-19 | Beckman Coulter, Inc. | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to ge |
| 2023-12-19 | Beckman Coulter, Inc. | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to ge |
| 2023-12-19 | Beckman Coulter, Inc. | Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to ge |
| 2019-10-28 | Beckman Coulter Inc. | Customers have reported incidents where two sets of results report the same Specimen Identifier (Specimen ID) with different results, different Medical Record Number (MRN) and diff |
| 2013-03-31 | Sysmex America, Inc. | The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the soft |
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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.