Detergent
Pathology · 21 CFR 864.4010
Recent MDR events
31 adverse event reports on file
- ALOE VESTA 2N1 BODY WASH/SHMPDec 18, 2015InjuryConvatec Inc.1049092-2015-31301
- FIRST STEP BEDSIDE PRECLEAN KITFeb 24, 2015Cygnus MedicalMW5041020
- ACT 5DIFF RINSEJun 26, 2013MalfunctionBeckman Coulter1061932-2013-01172
- ACT 5DIFF RINSEJun 18, 2013MalfunctionBeckman Coulter1061932-2013-01158
- ACT 5DIFF RINSEJun 17, 2013MalfunctionBeckman Coulter1061932-2013-01169
- ACT 5DIFF RINSEJun 17, 2013MalfunctionBeckman Coulter1061932-2013-01177
- ACT 5DIFF RINSEJun 15, 2013MalfunctionBeckman Coulter1061932-2013-01170
- ACT 5DIFF RINSEJun 12, 2013MalfunctionBeckman Coulter1061932-2013-00958
- KIT ELECSYS CLEAN-CELL M 2X2 LJan 30, 2013InjuryRoche Diagnostics1823260-2013-00522
- KIT CWS I/NAOH-D/BASIC WASHDec 13, 2012InjuryRoche Diagnostics1823260-2012-06312
Event type breakdown
Recalls
3 recall events for this product code
- Microcare MedicalOpen, ClassifiedSep 23, 2024
Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GV
Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter asburiae, Enterobacter bugandensis, pathogenic and opportunistic bacteria, to occur in ultrasonic detergent, which caused product bloating/leaking, and if used during medical/dental procedures could result in urinary tract, respiratory, bloodstream infections; workers handling contaminated product/instruments also at risk
Z-3209-2024 · View FDA record ↗ - Beckman Coulter Inc.TerminatedJun 20, 2014
Coulter DxH Cleaner 5L, Part No. 628022.
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.
Z-1830-2014 · View FDA record ↗ - Beckman Coulter Inc.TerminatedJun 20, 2014
Coulter DxH Cleaner 10L, Part No. 628023.
Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), automated white blood cell differential and the reticulocyte.
Z-1831-2014 · View FDA record ↗
Registered firms
45 firms currently registered for this product code
Predo Saglik Urunleri Sanayi Ve Ticaret Anonim Sirketi
SEHITKAMIL Gaziantep, TR
Infitek Co., Ltd.
Shanghai, CN
Urit Medical Electronic Co., Ltd.
Guilin Guangxi, CN
Copan Wasp
Brescia Lombardy, IT
Diatron Mi Plc
Budapest, HU
Technoclone
Vienna Wien, AT
Microcare Medical
Commerce City, CO, US
Siemens Healthcare Diagnostics Products Gmbh
MARBURG Hesse, DE
Weiman Products, Llc
GURNEE, IL, US
Patterson Dental Supply, Inc.
ST. PAUL, MN, US
Beckman Coulter, Inc.
HIALEAH, FL, US
Thermo Fisher Scientific Oy
VANTAA Uusimaa, FI
Carolina Liquid Chemistries
Brea, CA, US
Clinical Diagnostic Solutions, Inc.
PLANTATION, FL, US
Diagnostic Grifols, S.a.
PARETS DEL VALLES Barcelona, ES
Technogenetics Spa
LODI, IT
Medical Chemical Corporation
TORRANCE, CA, US
Abbott Laboratories
Lake Forest, IL, US
The Binding Site
Kings Norton Birmingham, GB
Beckman Coulter, Inc.
Miami, FL, US
Mindray Ds Usa, Inc.
Mahwah, NJ, US
Microcare Ct - John Downey
New Britain, CT, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Avantor Performance Materials Poland S.a.
Gliwice Slaskie, PL
Shenzhen Mindray Bio-medical Electronics Co., Ltd.
Shenzhen Guangdong, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.