BC-3D Control
Catalogue number BC-3D, listed by Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China, under Mixture, Hematology Quality Control. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| B&E BIO-Technology Co., Ltd. | Yantai | Shandong | Manufacturer | 9 |
Record
| Listed by | Shenzhen Mindray BIO-Medical Electronics Co., Ltd., China |
|---|---|
| FDA product code | JPK |
| Device type | Mixture, Hematology Quality Control |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K843962 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BC-3D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 140 |
| Liquichek | Bio-Rad Laboratories Inc. | 34 |
| Para 4 | Streck LLC | 17 |
| Drew Scientific | Drew Scientific, Ltd. | 15 |
| CVA | Streck LLC | 9 |
| Stat Profile | Nova Biomedical Corporation | 8 |
| Coulter 5C | Beckman Coulter, Inc. | 8 |
| Retic-Chex II | Streck LLC | 7 |
| BD Multi-Check | Becton, Dickinson AND Company | 6 |
| Cell-Chex Auto | Streck LLC | 6 |
| Coulter 4C-ES | Beckman Coulter, Inc. | 5 |
| Trinity Biotech | Primus Corp. | 4 |
Showing 12 of 97. All products under Mixture, Hematology Quality Control
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| R & D Systems, Inc. | 510(k) number | 2022-11-07 | Class III | Under Investigation by firm | For one lot of CBC-3D Hematology Control, the Normal Level may exhibit hemolysis or deterioration due to microbial contamination. | 8,259 kits, 28,136 labeled loose tubes, and 15,926 unlabeled | 2026-05-26 |
| Horiba Instruments Incorporated | 510(k) number | 2012-09-14 | Class III | Nonconforming Material/Component | 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. | 22,954 | 2013-04-22 |
| R & D Systems, Inc. | 510(k) number | 2004-04-15 | Not classified | Other | Clots in hematology controls resulted in low red blood cell counts when used in blood analyzers because control values were outside the expected range due to the clotting which took place after manufacturing. | 29494 vials of the normal controls and 15196 of the high con | 2004-06-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.