Beckman Coulter Sample Probes with Defective Tips Clinical Chemistry
Beckman Coulter is recalling sample probes with defective tips used in clinical chemistry analyzers. The defective probes may dispense lower sample concentrations, potentially leading to false low test results and delayed diagnosis.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is a Class II medical device recall involving a high-risk hazard (inaccurate diagnostic results leading to delayed treatment) where no illnesses or injuries have been reported. The potential for patient harm is significant due to the nature of false test results in clinical diagnosis, meeting the criteria for a High severity rating.
Plain-English summary
Beckman Coulter Mishima K.K. is recalling sample probes with defective probe tips. The affected probes are used with clinical chemistry analyzers to dispense samples into cuvettes. Lot numbers range from 178713114 to 179433670, with approximately 6,166 units affected.
When sample probes with defective tips are used, they may dispense a lower concentration than intended. This reduced concentration may not be detected by quality control checks, potentially resulting in false low test results. According to the manufacturer, errors of up to 34% have been observed at 1.0 microliter sample dispensing volumes and 7% at 1.6 microliter volumes. False low results could lead to delayed recognition and treatment of patient conditions.
The affected probes have been distributed worldwide, including throughout the United States and to numerous countries internationally. Healthcare facilities and laboratories using Beckman Coulter AU680 analyzers with affected sample probes should stop using them immediately and contact the manufacturer for replacement units or further instructions.
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.
- Affected units
- 6,166
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
Part of a larger recall action
This product is one of 2 recalled by Beckman Coulter Mishima K.K. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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