Device, Automated Sedimentation Rate
Hematology · 21 CFR 864.5800
Recent MDR events
5 adverse event reports on file
- MINIISEDNov 8, 2024MalfunctionAlcor Scientific Llc.20640868
- BD ACCU-SED®ESR BI-LEVEL CONTROLOct 15, 2018MalfunctionBecton Dickinson2243072-2018-01473
- ACCU-SED®ESR BI-LEVEL CONTROLJul 18, 2018MalfunctionBecton Dickinson2243072-2018-00477
- ELAN VESMATIC 20Oct 2, 2001Malfunction*MW1022986
- VACU-TEC TUBES IN THE VES-MATIC ESR TESTING SYSTEMJun 12, 2001MalfunctionDiesse Diagnostica Senese SriMW1022192
Event type breakdown
Most-reported manufacturers
Recalls
3 recall events for this product code
- Mechatronics USAOpen, ClassifiedJun 7, 2023
RR Mechatronics Starrsed Control Level N ESR Control 4.6 ml QRR049001- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythro
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 result will be flagged as out of range.
Z-1694-2023 · View FDA record ↗ - Mechatronics USAOpen, ClassifiedJun 7, 2023
RR Mechatronics Control Level A ESR Control4.6 ml QRR049002- In-vitro diagnostic quality control material to monitor the precision of Starrsed Erythrocyte Sed
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 result will be flagged as out of range.
Z-1695-2023 · View FDA record ↗ - Alcor Scientific, Inc.Open, ClassifiedUnknown
iSED Primary Pump Tubing Spare Part Kit- (IVD) tubing is used to move sample and wash solution from the aspiration needle, through the reading chamber, and to t
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
Z-1751-2022 · View FDA record ↗
Registered firms
17 firms currently registered for this product code
Sarstedt Ag & Co. Kg
NUMBRECHT North Rhine-Westphalia, DE
Sysmex America, Inc. - Vernon Hills
Vernon Hills, IL, US
Lp Italiana Spa
MILAN Milano, IT
Airscan, Inc.
Annandale, NJ, US
Elitechgroup Inc
LOGAN, UT, US
Rr Mechatronics Manufacturing B.v.
ZWAAG Noord-Holland, NL
Mechatronics Usa
WARWICK, RI, US
Streck Llc
La Vista, NE, US
Alifax Srl
Nimis Udine, IT
Scitek Global Co.,ltd
Jinan Shandong, CN
Alcor Scientific Llc
Smithfield, RI, US
Diesse Diagnostica Senese S.p.a
MONTERIGGIONI Siena, IT
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Shenzhen Yhlo Biotech Co., Ltd.
Shenzhen Guangdong, CN
Strumed Solutions Private Limited
Surat Gujarat, IN
Labpeak Co.,ltd
Jinan Shandong, CN
Sterile Safequip & Chemicals Limited
Ahmedabad Gujarat, IN
510(k) clearances
2 clearances for this product code