Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, N3660800/14987666536063, N3912400/14987666537084, N3912500/14987666537091, N3150700, N3151000, N3151300, N3151400, N3151500, N3151600, N3151900/ Serial: From 10155 to 2025021482. Sample Probe: MU993400/04987666522939, Lots: From 178713114 to 179433670. B66751 Kits containing MU993400, Lots: From 178713114 to 179433670
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Beckman Coulter Mishima K.K.
- Reason for Recall:
- A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing. The air layer is the air space that separates the cleaning water filled in the probe from the sample sucked into the probe. Maintaining this air space prevents the cleaning water and the sample from mixing. In the defective S probe, the "air layer" was not properly formed, causing the cleaning water and the sample to mix diluting the sample. As a result, the sample mixture dispensed into the cuvette has a lower concentration than the original sample, and the analyte concentration measured is lower than expected results.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Product Codes/Lot Numbers:
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, N3660800/14987666536063, N3912400/14987666537084, N3912500/14987666537091, N3150700, N3151000, N3151300, N3151400, N3151500, N3151600, N3151900/ Serial: From 10155 to 2025021482. Sample Probe: MU993400/04987666522939, Lots: From 178713114 to 179433670. B66751 Kits containing MU993400, Lots: From 178713114 to 179433670
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1907-2025
Related Recalls
Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 - 179433670
Beckman Coulter Mishima K.K.
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.
Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.
There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient order and a calibration order. When a patient sample and a non-barcoded calibrator tube is processed on the rack, the calibration result will be reported as a patient result. Issue 2: calibration with expired calibrator. They both may cause erroneous patient results, but the probability of serious adverse health consequences or death is unlikely.