Products, Red-cell Lysing Products
Hematology · 21 CFR 864.8540
Recent MDR events
78 adverse event reports on file
- BD FACS¿ LYSING SOLUTION 10X CONCENTRATESep 12, 2022MalfunctionBecton, Dickinson And Company, Bd Biosciences2916837-2022-00251
- BD FACS LYSING SOLUTION 10X 150 TESTSNov 15, 2021MalfunctionBecton, Dickinson And Company, Bd Biosciences2916837-2021-00437
- BD FACS LYSING SOLUTIONJan 13, 2021MalfunctionBecton, Dickinson And Company, Bd Biosciences2916837-2021-00021
- COULTER ACT 5 DIFF WBC LYSESep 17, 2014MalfunctionBeckman Coulter1061932-2014-02354
- DXH CELL LYSEFeb 26, 2012MalfunctionBeckman Coulter, Inc.1061932-2012-00606
- DXH CELL LYSEFeb 21, 2012MalfunctionBeckman Coulter, Inc.1061932-2012-00562
- IMMUNO-PREP REAGENT SYSTEMFeb 14, 2012MalfunctionBeckman Coulter, Inc.1061932-2012-00505
- IMMUNOPREP REAGENT SYSTEMDec 16, 2011MalfunctionBeckman Coulter, Inc.1061932-2011-02685
- DXH 800 CELL LYSENov 8, 2011MalfunctionBeckman Coulter, Inc.1061932-2011-02088
- COULTER AC.T 5DIFF WBC LYSEOct 21, 2011MalfunctionBeckman Coulter, Inc.1061932-2011-01901
Event type breakdown
Recalls
7 recall events for this product code
- Mckesson Medical-Surgical Inc. Corporate OfficeOpen, ClassifiedAug 26, 2022
BECKMAN COULTER, INC.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Z-1629-2022 · View FDA record ↗ - Beckman Coulter Inc.TerminatedSep 19, 2011
COULTER DxH Cell Lyse, Part number 628018(1L) and 628019 (5L).
The recall was initiated because Beckman Coulter identified unexpected high particle counts in the lots of DxH Cell Lyse listed. These lots may generate high background counts; could result in a falsely elevated Total Nucleated Count (TNC) of up to 50 cells/L; or may also result in recovery of TNC values that were higher than expected for Level 1 of the Body Fluid Control.
Z-3263-2011 · View FDA record ↗ - Sysmex America, Inc.TerminatedAug 23, 2011
Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is su
The affected lots of Stromatolyser-IM lysing reagent were found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.
Z-3063-2011 · View FDA record ↗ - Sysmex America, Inc.TerminatedJul 13, 2011
Sysmex Stromatolyser-IM; a lytic reagent for use with the XE-2100, XE-2100L and XE-5000 Series Sysmex Automated Hematology Analyzers; the reagent solution is su
The affected lots of Stromatolyser-IM lysing reagent was found to be contaminated with Pseudomonas bacteria, which resulted in rising IMI channel background counts, increased false "Platelet Clump" flags and a strong sulfur-like odor when used on the XE-2100, XE-2100L and XE-5000 analyzers.
Z-2797-2011 · View FDA record ↗ - Beckman Coulter Inc.TerminatedMay 20, 2011
COULTER Ac"T" 5diff Fix Reagent.
The recall was initiated because Beckman Coulter has confirmed that an issue has been identified with one of the raw materials used to manufacture the Coulter A T 5 diff PN 8547171.
Z-2231-2011 · View FDA record ↗ - Beckman Coulter Inc.TerminatedMay 19, 2011
COULTER LYSE S III diff Lytic Part Number: 8546796.
The recall was initiated by Beckman Coulter because the COULTER LYSE III diff Lytic Reagent Lot number 101554F was released for distribution to customers between November 17 and December 1, 2010 prior to completion of QC testing.
Z-2213-2011 · View FDA record ↗ - Abbott LaboratoriesTerminatedMay 14, 2008
White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems, Red cell lysing reagent, List Number 01H77-01, Supplied in 3.8L
Microbial Contamination: The WBC (White Blood Cell) Reagent Part A was confirmed positive for Pseudomonas contamination.
Z-1103-2008 · View FDA record ↗
Registered firms
50 firms currently registered for this product code
Sysmex Corporation Ono Factory
Ono Hyogo, JP
Abbott Gmbh
Wiesbaden Hesse, DE
Stemcell Technologies
Vancouver British Columbia, CA
Cancer Diagnostics, Inc.
Durham, NC, US
Abbott Laboratories
Irving, TX, US
Beckman Coulter, Inc.
Hebron, KY, US
B&e Bio-technology Co., Ltd.
Yantai Shandong, CN
Zhejiang Gene Science Co., Ltd
shaoxing Zhejiang, CN
Abbott Laboratories
Lake Forest, IL, US
Beckman Coulter, Inc.
CARLSBAD, CA, US
Diatron Mi Plc
Budapest, HU
Beckman Coulter, Inc.
HIALEAH, FL, US
Atsi Logistics Center Aps
GLOSTRUP Hovedstaden, DK
Sysmex Corporation Techno Park
KOBE Hyogo, JP
Beckman Coulter Ireland Inc
O CALLAGHANS MILLS Clare, IE
Tosoh Bioscience, Inc.
Grove City, OH, US
Diatron Us Inc
Medley, FL, US
Fisher Diagnostics
MIDDLETOWN, VA, US
Antibodies Incorporated
DAVIS, CA, US
Immunotech Sas, A Beckman Coulter Company
MARSEILLE, CEDEX 9 Bouches-du-Rhone, FR
Agilent Technologies Singapore (international) Pte Ltd.
Singapore North East, SG
Sysmex Europe Se
Neumunster Schleswig-Holstein, DE
Lab Warehouse Inc.
Lajas, PR, US
Sysmex Corporation
KOBE Hyogo, JP
Sysmex America, Inc.
Lincolnshire, IL, US
510(k) clearances
29 clearances for this product code
- Coulter ImmunologyNov 30, 1988
K883836 · COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
- Kvm Technologies, Inc.Oct 12, 1988
K883991 · KVM HEMOGLOBIN LYSING REAGENT
- Fisher Scientific Co., LLCOct 20, 1987
K874054 · FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
- Abbott DiagnosticsSep 9, 1987
K873348 · CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
- J. D. Assoc.Nov 6, 1986
K863114 · PIASTRINIT
- Reagent Laboratory, Inc.Oct 3, 1986
K863503 · HEMOLYSE
- Nobel Scientific Industries, Inc.Mar 29, 1985
K850944 · NSI LYSING-D REAGENT -4000 ML
- Hematology Marketing Assoc.Mar 29, 1985
K850097 · LASER-LYSE