Recall Z-1908-2025 — Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
U.S. FDA — Device Enforcement · Japan · 2025-04-30 · Class II
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Reported risk: Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of false low test results (Max 34% error at 1.0 microliters and 7% error at 1.6 microliters sample dispensing volume), which may lead to delayed recognition and treatment.
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