[pending] Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount int
Pending LLM rewrite. Source: FDA_DEVICE Z-1908-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
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 — Devices
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: AU680: B12185/14987666540732
- B12186/14987666540688
- B12187/14987666540701
- B12188/14987666540725
- B96694/14987666542989
- B96695/14987666542996
- B96696/14987666543009
- C02656/14987666543306
- C02657/14987666543313
- N3147700/15099590346249
- N3662000/14987666535301
- N3662100/14987666535318
- N3662200/14987666535325
- N3662700/14987666535615
- N3663000/14987666535646
- N3910200/14987666535790
- N3910400/14987666535813
- N3910500/14987666535820
- N3910600/14987666535912
- N3910800/14987666535936
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27