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Device, Automated Sedimentation Rate
FDA product code GKB · Class 1 · Hematology
93
Registered devices
5
Adverse events
3
Recalls
2
510(k) clearances
Devices with this code
JO-PLUS — ALIFAX SRLLATEX CALIBRATORS — ALIFAX SRLExcyte® ESR Vacuum Tubes, Carton — ELITECHGROUP INC.LATEX EQE (2 TEST) — ALIFAX SRLExcyte® — ELITechGroup B.V.Starrsed — Mechatronics USA LLCStarrsed — Mechatronics USA LLCExcyte® — ELITechGroup B.V.Starrsed — Mechatronics USA LLCStarrsed — Mechatronics USA LLCStarrsed — Mechatronics USA LLCTEST1 YDL — ALIFAX SRLTEST1 2.0 — ALIFAX SRLVISION ESR Analyzer — Shenzhen YHLO Biotech Co., Ltd.Excyte® ESR Vacuum Tube, Carton — ELITECHGROUP INC.VISION ESR Analyzer — Shenzhen YHLO Biotech Co., Ltd.Starrsed — Mechatronics USA LLCVES-MATIC ORIGINAL — DIESSE DIAGNOSTICA SENESE SPAMINI-CUBE — DIESSE DIAGNOSTICA SENESE SPAStarrsed Control — RR Mechatronics Manufacturing B.V.Starrsed — Mechatronics USA LLCQBC Diagnostics — DRUCKER DIAGNOSTICSiSED Elite — ALCOR SCIENTIFIC INC.Starrsed Disinfectant — RR Mechatronics Manufacturing B.V.
Recent 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 |
| 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 |
| 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 iSED |
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