Mixture, Hematology Quality Control
Hematology · 21 CFR 864.8625
Recent MDR events
93 adverse event reports on file
- BD MULTI-CHECKJul 20, 2023MalfunctionBecton Dickinson And Company Bd Biosciences2916837-2023-00143
- BD MULTI-CHECKJul 20, 2023MalfunctionBecton Dickinson And Company Bd Biosciences2916837-2023-00144
- XN-L CHECKNov 12, 2021InjurySysmex Corporation Techno Park1000515253-2021-00015
- BD MULTI-CHECK CD4 LOW CTRL 1X2.5ML US-IVDOct 23, 2020MalfunctionBecton, Dickinson And Company, Bd Biosciences2916837-2020-00206
- BD ESR¿ BI-LEVEL QC MATERIAL (4X8,5ML)May 7, 2019MalfunctionBecton Dickinson2243072-2019-00871
- R & D SEDRITE PLUSNov 25, 2014MalfunctionR & D Systems2182501-2014-00001
- BODY FLUID CONTROLJun 14, 2012MalfunctionBeckman Coulter, Inc.1061932-2012-01906
- GPS III KITMay 25, 2012InjuryBiomet Biologics0001825034-2012-00683
- COULTER AC.T 5DIFF CONTROL PLUSDec 15, 2011MalfunctionBeckman Coulter, Inc.1061932-2011-02663
- 4C-ES CELL CONTROLDec 7, 2011MalfunctionBeckman Coulter, Inc.1061932-2011-02583
Event type breakdown
Recalls
16 recall events for this product code
- R & D Systems, Inc.TerminatedJan 19, 2023
R&D CBC-3D Hematology Control:
For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination.
Z-0999-2023 · View FDA record ↗ - Primus Corporation dba Trinity BiotechTerminatedDec 1, 2022
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. The unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.
Z-0349-2023 · View FDA record ↗ - Primus Corporation dba Trinity BiotechTerminatedDec 1, 2022
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.
Z-0350-2023 · View FDA record ↗ - Clinical Diagnostic SolutionsTerminatedApr 9, 2014
Boule Con-Diff Tri-Level
Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots.
Z-1436-2014 · View FDA record ↗ - Horiba Instruments, Inc dba Horiba MedicalTerminatedNov 21, 2012
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High).
HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot #MX090 (Level High). Customer communication was sent 10/01/2010.
Z-0429-2013 · View FDA record ↗ - Clinical Diagnostic SolutionsTerminatedNov 5, 2012
Boule Con Diff US Tri Pack, 6 Vials.
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule
Z-0193-2013 · View FDA record ↗ - Clinical Diagnostic SolutionsTerminatedNov 5, 2012
Boule Con-Diff Hematology Control 9 vials.
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule
Z-0194-2013 · View FDA record ↗ - Clinical Diagnostic SolutionsTerminatedNov 2, 2012
Boule Con-Diff Hematology Control
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai
Z-0189-2013 · View FDA record ↗ - Clinical Diagnostic SolutionsTerminatedNov 2, 2012
Boule Con-Diff Hematology Control
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai
Z-0190-2013 · View FDA record ↗ - Clinical Diagnostic SolutionsTerminatedNov 2, 2012
Boule Con-Diff Hematology Control
Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complai
Z-0191-2013 · View FDA record ↗
Registered firms
155 firms currently registered for this product code
Horiba Instruments Incorporated
Canton, MI, US
Streck Llc
La Vista, NE, US
Nova Biomedical Corporation
WALTHAM, MA, US
Becton, Dickinson And Company, Bd Biosciences
Milpitas, CA, US
Sysmex America, Inc.
Lincolnshire, IL, US
Airscan, Inc.
Annandale, NJ, US
Abbott Laboratories
Lake Forest, IL, US
Nova Biomedical Corporation
Billerica, MA, US
Beckman Coulter, Inc.
HIALEAH, FL, US
Microgenics Corporation
Fremont, CA, US
Sysmex Corporation Techno Park
KOBE Hyogo, JP
Mindray Ds Usa, Inc.
Mahwah, NJ, US
Bio-rad Laboratories Inc.
IRVINE, CA, US
Bio-rad Laboratories Inc.
Irvine, CA, US
Bionostics, Inc.
Devens, MA, US
Advanced Instruments, Llc
NORWOOD, MA, US
510(k) clearances
192 clearances for this product code
- StreckDec 22, 2016
K160588 · XN CHECK BF
- StreckDec 22, 2016
K160590 · XN CHECK
- StreckDec 22, 2016
K160586 · XN-L CHECK
- R&D Systems, Inc.Sep 1, 2016
K160606 · BC-5D Hematology Control
- StreckDec 5, 2014
K141964 · XN CHECK
- StreckDec 5, 2014
K141957 · XN CHECK BF
- R&D Systems, Inc.Jul 24, 2013
K130962 · R&D 5D RETIC HEMATOLOGY CONTROL
- StreckOct 19, 2012
K120744 · XN CHECK BF