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CREA
RANDOX LABORATORIES LIMITED · Model CR3814 · UDI-DI 05055273201895
CGX
Prescription
1
510(k) clearances
394
Adverse events
15
Recalls
41
Facilities
Description
The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine
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 Dimension CRE2 quali |
| 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 lots received between 0 |
| 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 for Atellica CH. |
| 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 kits. |
| 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 catalytic on aminoantip |
| 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 manual procedure, no resu |
| 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 quality control freque |
| 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 to fail and prevented |
| 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 FA2237 when processi |
| 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 that has been puncture |
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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.