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Excyte 20
ELITECHGROUP INC. · Model 20 (8 mm) · UDI-DI 03661540304415
2
510(k) clearances
5
Adverse events
3
Recalls
17
Facilities
Description
Automated Erythrocyte Sedimentation Rate (ESR) Analyzer
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-04-14 | Mechatronics USA | QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument r |
| 2023-04-14 | Mechatronics USA | QRR049001 Lot QCAB6AN505 incorrectly labelled as QRR049002 Lot QCAB6AAA28. The incorrectly labelled vial will upload the range for the Starrsed Control Level A and the instrument r |
| 2022-07-20 | Alcor Scientific, Inc. | Primary Pump Tubing Spare Part is incorrect. If the tubing is installed onto an ALCOR iSED ESR Analyzer, there is a potential of a biohazard leak from the iSEDs Probe Tube |
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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.