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Synermed®
INFRARED LABORATORY SYSTEMS LLC · Model UV311B-L · UDI-DI 05060500090708
CGS
Prescription
1
510(k) clearances
1,513
Adverse events
10
Recalls
26
Facilities
Description
Creatinine Kinase Enzyme/Coenzyme 6 X powder vials
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.