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CK
RANDOX LABORATORIES LIMITED · Model CK2813 · UDI-DI 05055273201468
CGS
Prescription
1
510(k) clearances
1,513
Adverse events
10
Recalls
26
Facilities
Description
The CK method used on the Dimension clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of creatine kinase activity 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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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.