Who else makes this device?

Name: Minotrol 16
Brand: Minotrol 16

Hematology › ReagentsMixture, Hematology Quality Control

Minotrol 16

3 catalogue numbers from 6x2.5mL, listed by Horiba Instruments Incorporated, United States, under Mixture, Hematology Quality Control. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

3catalogue numbers in this listing

1recall

Who Else Makes It

Concentrated in Jilin (1), Guangdong (1), Shandong (1).

Chinese manufacturers registered for FDA product code JPK
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

Regulatory record for Minotrol 16
Listed by	Horiba Instruments Incorporated, United States
FDA product code	JPK
Device type	Mixture, Hematology Quality Control
Device class	Class 2
Regulation	21 CFR 864.8625
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published	2016-08-03
Record revised	2018-03-29 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Minotrol 16
Catalogue number	Size	Status
6×2.5mL		In distribution
12×2.5mL		In distribution
3×2.5mL		In distribution

Same Product Code

Other products under the same FDA 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

1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
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

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.