Beckman Coulter iChemVELOCITY Urine Chemistry System Recalled for Probe Misalignment
Beckman Coulter is recalling iChemVELOCITY Urine Chemistry Systems because probe misalignment or bending can lead to delayed or incorrect patient results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect patient results, which is a risk-of-harm product issue where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Beckman Coulter Inc. is recalling the iChemVELOCITY Urine Chemistry System, including various catalog numbers such as 800-3530, 800-7167, and 800-7719. The recall involves 3,175 units total, with 1,697 units distributed in the United States and the remainder distributed internationally to numerous countries.
The recall is being conducted because probe misalignment or bending has the potential to lead to a delay in reporting results or incorrect patient results. The iChemVELOCITY system is an automated urine chemistry analyzer intended for in vitro measurement of various analytes in urine, including ketones, blood, protein, glucose, bilirubin, urobilinogen, nitrite, leukocyte esterase, specific gravity, pH, ascorbic acid, color, and clarity.
The source text does not specify specific actions for consumers or healthcare providers, such as whether to stop using the device or contact the manufacturer for a repair or replacement. Users of the affected devices should refer to the official FDA recall notice for specific instructions.
The recalled product
- Product
- iChemVELOCITY Urine Chemistry System, Catalog No. 800-3530, 800-7167, 800-7719, 800-7720, 800-3564, 800-7100, 800-7103, 800-7106, 800-7162, 800-7163, 800-7166, 800-3061. The iChem Velocity automated urine chemistry system is used to test for the following analytes in urine: keto
- Manufacturer
- Beckman Coulter Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Number V01257 V02416 V02619 V01444 V02906 V02959 V03934
- V03933 V02027
- V02022
- V01251 V01115 V02081 V02248 V03575 V03854 V03403 V04387 V04388
- V01406 V01556 V04328 V04390
- V01557 V04141 V02103 V01214 V04227
- V03413 V01753
- V02753 V01541 V01542 V02369
- V02086 V01467 V03100 V01872 V04138 V02047 V02210 V03221 V03003 V03285
- V03283 V02025 V01179 V01182 V03033 V02361 V01842 V02931 V01717
- V04377 V03776 V01831 V03890 V01335 V01567
- V01632
- V01633 V04318 V03008 V03011
- V03953 V01876 V01147 V03797 V02809 V03467 V03700 V03775 V04335
- V03357 V02180 V01376 V01978
- V03106
- V03107 V02269 V01713 V03384 V03716 V02808 V01620 V03858 V01649 V02295
- V02306 V02468 V01059 V04372 V01645 V03441
- V01159 V01393 V04279 V03383 V01730 V01046 V01274 V02717 V03958
- V01078
Distribution
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