Beckman Coulter, Inc.: DxI 9000 Immunoassay Analyzers Recalled for Potential Erroneous Lab Results

What You Should Do

1. Identify if your laboratory is using an affected DxI 9000 Access Immunoassay Analyzer (Model C11137) by checking the serial number on the instrument. Affected serial numbers include: 300116, 300117, 300123 through 300131, 300133 through 300139, 300141 through 300143, 300145 through 300158, 300160 through 300164, 300166 through 300172, 300174, 300176, 300178 through 300183, 300188 through 300224, 300226 through 300249, 300251 through 300261, 300263, 300264, 300266, 300269 through 300277, 300279 through 300295, and 300297 through 300306.
2. Review your laboratory procedures to ensure that operators are only scanning barcodes from a single, matching calibrator card when configuring new lots, as the system will currently accept mismatched cards without warning.
3. Be aware that this issue specifically impacts calibrator materials that do NOT use 2D barcodes; materials with 2D calibrator card barcodes are not affected.
4. Contact your Beckman Coulter representative or the manufacturer's technical support directly to discuss necessary software corrections or field service updates.
5. If you are a patient who recently had blood or fluid work processed on a DxI 9000 system and are concerned about your results, contact your healthcare provider for guidance.
6. For further information regarding this medical device recall, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products