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Research and Diagnostic Systems
RESEARCH AND DIAGNOSTIC SYSTEMS, INC. · Model CL018 · UDI-DI 00815762020667
JPK
Prescription
1
510(k) clearances
93
Adverse events
16
Recalls
31
Facilities
Description
CBC-LINE Kit: 6 x 3mL (6 vials each of the various levels) RBC Levels 1-4,6,7 WBC Levels 1,3,6,8,10,11 PLT Levels 1,4,7,10,12,13 Low Levels 1-6
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. The unacceptable Control Level 1 value |
| 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 the firm, the unacce |
| 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 #MX090 (Level High) |
| 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 501-607, Lot #1102-576; an |
| 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 501-607, Lot #1102-576; an |
| 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 501-607, Lot #1102-576; an |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.