Beckman Coulter Sample Probe Manufacturing Defect Recall
Beckman Coulter Mishima is recalling sample probes due to a manufacturing defect where rounded and chamfered corners prevent proper air layer formation, causing sample dilution and inaccurate test results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. No reported illnesses, injuries, or deaths are mentioned in the source. The hazard involves inaccurate measurement output rather than direct physical injury, and the source text contains no evidence of actual harm. This fits the Moderate criteria for Class II recalls without reported adverse outcomes.
Plain-English summary
Beckman Coulter Mishima K.K. is recalling sample probes (model MU993400) distributed worldwide, including nationwide across the United States and to numerous countries. The defective probes have rounded and chamfered corners on the tip that prevent proper formation of the air layer—the air space that normally separates cleaning water from the sample during dispensing.
In affected probes, the air layer does not form properly, allowing cleaning water and sample to mix. This dilution causes the sample placed into the cuvette to have a lower concentration than the original sample, resulting in measured analyte concentrations that are lower than expected.
Affected units include sample probes with lot numbers ranging from 178713114 to 179433670, and B66751 kits containing these probes with the same lot range. The device is used in laboratory testing equipment from Beckman Coulter. Customers who have received affected devices should contact Beckman Coulter Mishima K.K. for replacement or further guidance.
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.
- Hazard
- manufacturing-defect
- inaccurate-test-results
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)
- Device: REF/UDI-DI/Serial-Lot: AU480: B11810/14987666540664
- B12183/14987666540671
- B80091/16954701010015
- B96692/14987666542965
- B96693/14987666542972
- C02654/14987666543283
- C02655/14987666543290
- C02845/16954701010022
- C41919/14987666544174
- C41920/14987666544181
- N3659700/14987666535257
- N3659800/14987666535264
- N3659900/14987666535271
- N3660000/14987666535288
- N3660100/14987666535547
- N3660200/14987666535554
- N3660300/14987666535554
- N3660400/14987666535769
- N3660500/14987666536032
- N3660600/14987666536049
Distribution
Distributed nationwide across the United States.
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