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Pointe Scientific, Inc.
HORIBA INSTRUMENTS INCORPORATED · Model H7546-CTL · UDI-DI 00811727014566
JPK
Prescription
1
510(k) clearances
93
Adverse events
16
Recalls
32
Facilities
Description
Liquid Hemoglobin A1c Control Set, The HbA1c controls are reference controls consisting of human blood based solutions. It is intended to simulate human patient whole blood samples for the purpose of monitoring the precision of laboratory testing procedures for the following assays: HbA1c. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. Size: 4 x 0.5 mL
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 the firm, the unacce |
| 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 |
| 2021-01-25 | 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.