🏥 Medical Devices • 6,554 recalls
Beckman Coulter
Beckman Coulter has identified that an incorrect setting using a proprietary software configuration tool can result in the Sample Prep Probe of the AQUIOS CL drawing aspirant from the wrong tube in a cassette which manifests in incorrect values being reported out of the laboratory for some patient samples.
The AlAT calibrator values in the package insert for the Multi-Analyte Calibrator, lot D755, lots N653 and lot N654 were not correct.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely elevated BEC Lipase recovery exceeding the total precision specification.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Leonhard Lang Medizintechnik GmbH
Certain lots of the defibrillation electrodes model DF59N and DF59NC may have a delay in connecting or not connect at all with the defibrillator ZOLL AED PLUS. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
The device history record (DHR) was missing its test documentation for final HIPOT (high potential) electrical testing.
Complaints were received reporting the system would freeze/shut down while in Fulgurate mode.
Some anomalies have been identified during manufacturing controls.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
A delay in transit may have contributed to nonconformity as the product was stored outside of defined shipping and handling temperature requirements.
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.
The software is not identifying the patient as having atypical hyperplasia, resulting in an incorrect Gail Risk calculation.
Beckman Coulter has determined that additional clarification for the Blast Suspect messages is necessary. In rare situations, the LH 750, LH 780, LH 500 and HmX Analyzers may not flag or detect blasts in some blood samples.
Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.
FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting).
Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.