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Ferritin AccuLite CLIA Test System - 192 Wells
MONOBIND, INC. · Model 2875-300 · UDI-DI 00816870021997
JMG
Prescription
10
510(k) clearances
83
Adverse events (1 deaths)
5
Recalls
17
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2019-07-15 | Siemens Healthcare Diagnostics, Inc. | Negative Bias with Lot EA9227. |
| 2017-03-10 | Beckman Coulter Inc. | Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration. |
| 2014-07-15 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has received complaints for the Dimension Chemistry Wash (RD701) of QC and patient sample result accuracy shifts on Troponin I, CTNI (RF421C), LTNI ( |
| 2013-05-06 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lo |
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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.