Home › Device types › GKB
Device, Automated Sedimentation Rate
FDA product code GKB · Class 1 · Hematology
92
Registered devices
5
Adverse events
3
Recalls
2
510(k) clearances
Devices with this code
Starrsed X-Clean — RR Mechatronics Manufacturing B.V.VISION ESR Analyzer — Shenzhen YHLO Biotech Co., Ltd.LATEX CONTROLS — ALIFAX SRLStarrsed — Mechatronics USA LLCVISION ESR Analyzer — Shenzhen YHLO Biotech Co., Ltd.LATEX EQE (2 TEST) — ALIFAX SRLStarrsed — Mechatronics USA LLCLATEX EQE (2 TEST) — ALIFAX SRLVISION ESR Analyzer — Shenzhen YHLO Biotech Co., Ltd.VISION ESR Analyzer — Shenzhen YHLO Biotech Co., Ltd.LATEX CONTROLS — ALIFAX SRLExcyte® — ELITechGroup B.V.QBC Diagnostics — DRUCKER DIAGNOSTICSSediplus® S 200, 12 V DC — Sarstedt Aktiengesellschaft & Co.KGminiiSED — ALCOR SCIENTIFIC INC.LATEX CALIBRATORS — ALIFAX SRLStarrsed Saline — RR Mechatronics Manufacturing B.V.ESR-Auto Plus — STRECK, INC.VISION ESR Analyzer — Shenzhen YHLO Biotech Co., Ltd.TEST1 YDL — ALIFAX SRLMINI-CUBE — DIESSE DIAGNOSTICA SENESE SPAVISION ESR Analyzer — Shenzhen YHLO Biotech Co., Ltd.Excyte® ESR Vacuum Tube — ELITECHGROUP INC.TEST1 THL — ALIFAX SRL
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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