Home › Device types › CGX
Alkaline Picrate, Colorimetry, Creatinine
FDA product code CGX · Class 2 · Clinical Chemistry
101
Registered devices
394
Adverse events
15
Recalls
159
510(k) clearances
Devices with this code
AU — Beckman Coulter, Inc.Creatinine Jaff method — Roche Diagnostics GmbHARCHITECT — ABBOTT LABORATORIESSynermed® — INFRARED LABORATORY SYSTEMS LLCYumizen C1200 Creatinine Jaffé — HORIBA ABX SASGENCHEM™ Creatinine Test Reagent — GENCHEM INCPiccolo General Chemistry 13 — ABAXIS, INC.Alinity — Abbott GmbHSynermed® — INFRARED LABORATORY SYSTEMS LLCCAROLINA LIQUID CHEMISTRIES CORP.® CREA RGT. KIT AU-243 — CAROLINA LIQUID CHEMISTRIES CORPORATIONTeco Diagnostics Creatinine (Kinetic) Reagent Set — TECO DIAGNOSTICSARCHITECT — Abbott GmbHDimension Vista® Flex® reagent cartridge CRE2 — Siemens Healthcare Diagnostics Inc.GENCHEM™ Creatinine Test Reagent — GENCHEM INCTeco Diagnostics Creatinine (Kinetic or Manual Endpoint Method) Reagent Set — TECO DIAGNOSTICSCAROLINA LIQUID CHEMISTRIES CORP.® CREA CREATININE REAGENT CC243 — CAROLINA LIQUID CHEMISTRIES CORPORATIONJAS Diagnostics — DREW SCIENTIFIC, INC.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDPointe Creatinine for BS480 — HORIBA INSTRUMENTS INCORPORATEDJAS Diagnostics — DREW SCIENTIFIC, INC.Synermed® — INFRARED LABORATORY SYSTEMS LLCAU — Beckman Coulter, Inc.CREATININE-S Assay — SEKISUI DIAGNOSTICS, LLCCREA — RANDOX LABORATORIES LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-18 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2020-06-05 | Siemens Healthcare Diagnostics, Inc. | Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 f |
| 2016-07-20 | Sterling Diagnostics, Inc. | Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the k |
| 2016-01-11 | Horiba Instruments Inc | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide cat |
| 2014-12-12 | Pointe Scientific, Inc. | Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manua |
| 2012-12-28 | Beckman Coulter Inc. | Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and qu |
| 2012-09-14 | Horiba Instruments, Inc dba Horiba Medical | This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration t |
| 2011-11-22 | Siemens Healthcare Diagnostics, Inc. | Siemens has confirmed the potential for falsely elevated creatinine results with CREA FLex(R) reagent cartridge lots GA2196, GA2203, DC2221, DB2221, GA2229 and |
| 2010-12-27 | Siemens Healthcare Diagnostics, Inc. | Firm has confirmed the potential for falsely elevated creatinine results with specified CREA Flex(R) reagent cartridge lots when processing tests from a well th |
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