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CK NAC

RANDOX LABORATORIES LIMITED · Model CK335 · UDI-DI 05055273201475

CGS Prescription

510(k) clearances

1,513

Adverse events

Recalls

Facilities

Description

The device is intended for the quantitative in vitro determination of creatine kinase in serum or plasma.

Recalls

Date	Firm	Reason
2025-11-03	GET TESTED INTERNATIONAL AB	Distribution without premarket approval/clearance.
2022-03-25	Randox Laboratories Ltd.	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 Pat
2019-05-03	Siemens Healthcare Diagnostics, Inc.	A steady upward trend in blank (u) absorbance was observed
2019-05-03	Siemens Healthcare Diagnostics, Inc.	A steady upward trend in blank (u) absorbance was observed
2018-07-18	Abbott Laboratories, Inc	The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
2018-07-18	Abbott Laboratories, Inc	The product has a stability issue which may lead to an error code indicating "Unable to calculate result, reaction check failure" and/or Quality Control results out of range low.
2017-06-29	Siemens Healthcare Diagnostics, Inc.	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele
2017-06-29	Siemens Healthcare Diagnostics, Inc.	Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele
2011-10-19	Medtest Holdings, Inc.	Linear performance information in product insert does not match that listed in the approved premarket notification
2007-10-12	Abbott Laboratories Inc.	Three potential issues with Creatine Kinase Lot Number: 52044HW00: (1) Decrease in quality control and/or patient results (2) An iIncreased imprecision, or (3) Error Code 1054 (U

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Data 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.