Sample probe defect causes inaccurate laboratory measurement results

Plain-English summary

Beckman Coulter Mishima K.K. is recalling approximately 10,176 sample probes used in their laboratory analyzer systems due to a manufacturing defect affecting the probe tip. The defect involves rounded and chamfered corners on the tip, which prevent the proper formation of the air layer required for normal probe operation.

The air layer is the air space that separates cleaning water inside the probe from the sample being analyzed. When the air layer does not form properly in the defective probes, cleaning water mixes with the sample, diluting it. This causes the sample dispensed into the analyzer cuvette to have lower concentration than the original sample, resulting in lower than expected analyte concentration measurements.

The affected sample probes were distributed worldwide to the United States (all states and territories) as well as to countries across Europe, Asia, Africa, South America, and the Middle East. Affected lot numbers range from 178713114 to 179433670.

Healthcare facilities and diagnostic laboratories using affected Beckman Coulter analyzers should contact the manufacturer for guidance on identifying and replacing affected sample probes. Laboratory test results obtained using the defective probes may not be reliable.

The recalled product

Product

Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670

Manufacturer

Beckman Coulter Mishima K.K.

Category

Medical Device

Hazard

• manufacturing-defect
• measurement-inaccuracy
• sample-dilution

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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