Who else makes this device?

Name: CK-MB CAL
Brand: CK-MB CAL

CK-MB CAL · Calibrator, Secondary → Clinical Chemistry

1manufacturer

1catalogue number

1510(k) clearance

2recalls on this code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code JIT
Manufacturer	City	Province	Registered as	Device types
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	4

Record

Regulatory record for CK-MB CAL
Listed by	Randox Laboratories Limited, United Kingdom
FDA product code	JIT
Device type	Calibrator, Secondary
Device class	Class 2
Regulation	21 CFR 862.1150
Establishment	Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
510(k)	K123977
Record published	2016-09-16
Record revised	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Special storage condition: Once reconstituted CK-MB is stable in the serum for 5 days at +4°C, 8 hours at +25°C and 4 weeks at → 20°C when frozen on; Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for CK-MB CAL
Catalogue number	Size	Status
CK2393		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Vitros	Ortho-Clinical Diagnostics, Inc.	39
Exact Diagnostics	Exact Diagnostics	30
Architect	Abbott Medical	26
Architect	Abbott Ireland	24
Alinity	Abbott Medical	18
Alinity	Abbott Ireland	16
Architect	Abbott Laboratories	15
Architect	Abbott Ireland Diagnostics	11
Alinity	Abbott Ireland Diagnostics	11
JAS Diagnostics	Drew Scientific, Ltd.	10
BioPlex 2200	Bio-Rad Laboratories Inc.	8
AU	Beckman Coulter, Inc.	6

Showing 12 of 391. All products under Calibrator, Secondary

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K142181	2014-09-18

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of CK-MB CAL
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Randox Laboratories Limited	UDI-DI	2022-03-25	Class III	Under Investigation by firm	Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.	1,392	2023-12-26

Recalls

2 of these are Class II. Class II means a temporary or reversible health consequence. 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
2024-01-31	Class II	Under Investigation by firm	Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.	8 units
2018-12-03	Class II	Under Investigation by firm	The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease	85 kits

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.

CK-MB CAL