Home › Device types › JPK
Mixture, Hematology Quality Control
FDA product code JPK · Class 2 · Hematology
439
Registered devices
93
Adverse events
16
Recalls
192
510(k) clearances
Devices with this code
Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.NOVA — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONPara 4 — STRECK, INC.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDResearch and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.COULTER LIN-C — Beckman Coulter, Inc.BC-3D Control — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.HemaTechnologies ESR Control — Airscan, Inc.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.Drew Scientific — DREW SCIENTIFIC, INC.UA-Cellular for IQ — STRECK, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.BD Multi-Check — Becton, Dickinson And CompanyResearch and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.BC-6D Hematology Control — Shenzhen Mindray Bio-Medical Electronics Co., Ltd.COULTER 6C — Beckman Coulter, Inc.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.Research and Diagnostic Systems — RESEARCH AND DIAGNOSTIC SYSTEMS, INC.BD Leucocount — Becton, Dickinson And CompanyCOULTER 4C-ES — Beckman Coulter, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-07 | R & D Systems, Inc. | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination. |
| 2021-10-05 | Primus Corporation dba Trinity Biotech | 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 |
| 2021-10-05 | Primus Corporation dba Trinity Biotech | 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 C |
| 2021-01-25 | Medline Industries Inc | Product was compromised during shipment. |
| 2020-10-05 | Becton, Dickinson and Company, BD Biosciences | Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating. |
| 2013-02-24 | Clinical Diagnostic Solutions | Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. |
| 2012-09-14 | Horiba Instruments, Inc dba Horiba Medical | HORIBA Medical Irvine Technical Support received reports from some customers that have experienced high recover values for Hemoglobin when using Minotrol 16 lot |
| 2011-03-24 | Clinical Diagnostic Solutions | 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 501-60 |
| 2011-03-24 | Clinical Diagnostic Solutions | 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 501-60 |
| 2011-03-24 | Clinical Diagnostic Solutions | 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 501-60 |
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