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Excyte® ESR Vacuum Tube, Carton
ELITECHGROUP INC. · Model EP-10605-H1 · UDI-DI 03661540300332
2
510(k) clearances
5
Adverse events
3
Recalls
17
Facilities
Description
ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).
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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