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IMMULITE®/IMMULITE® 1000 Systems ACT ACTH
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Model 10381415 · UDI-DI 00630414963532
1
510(k) clearances
33
Adverse events
6
Recalls
20
Facilities
Description
ACTH - IMMULITE - RGT - 100 Tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2018-11-30 | Tosoh Bioscience Inc | |
| 2011-12-13 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed that the DxH Slidemaker Stainer Floor Stand shipped with Slidemaker Stainer instruments were missing vinyl caps, expo |
| 2005-04-22 | Nichols Institute Diagnostics | Performance does not meet claims in the Directional Insert concerning correlation with the IRMA ACTH assay. |
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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.