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Microsed-System® Automated ESR Analyzer
ELITECHGROUP INC. · Model PRD-MSS-EL-08TKNE · UDI-DI 03661540300035
2
510(k) clearances
5
Adverse events
3
Recalls
17
Facilities
Description
The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human whole blood samples by laboratory professionals. Elevated ESR results indicate degrees of inflammation or disease present in the human body.
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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