Beckman Coulter Ichemvelocity recall
BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050…
Why was Beckman Coulter Ichemvelocity recalled?
Beckman Coulter has determined that there is a potential for incorrect settings to be installed on North American iChemVELOCITY Urine Chemistry Analyzers. 1. The installation of International settings can result in the generation of erroneous, false low results for some of the analytes at some concentrations. 2. The installation of colors different from those stated in the Instructions for Use (Colorless, Straw, Yellow, Amber, Red, Blue) for output settings will result in incorrect reporting of colors. For example, if Green is the color choice for the output setting instead of Blue, Green will be reported.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Fielded Serial Numbers with North American Configuration settings
- Product
- BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 2225 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Brazil, Canada, Malaysia, Singapore, Taiwan, Thailand, Turkey
- Recall date
- May 16, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)