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SEEKER™

Baebies, Inc. · Model 2188 · UDI-DI 00819704020197

KHO Prescription
10
510(k) clearances
4,519
Adverse events
32
Recalls
51
Facilities

Description

The SEEKER™ Instrument is a quantitative in vitro diagnostic instrument for the determination of clinical chemistry analytes.

Recalls

DateFirmReason
2020-05-22Tosoh Bioscience IncThe Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results.
2020-01-10Tosoh Bioscience IncA display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument firmware, causing the
2019-02-20Ortho-Clinical DiagnosticsLuminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
2019-02-20Ortho-Clinical DiagnosticsLuminometer Malfunction May Cause Inability to Process MicroWell Assays on VITROS Systems
2018-10-05Tosoh Bioscience IncTosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the ana
2018-10-05Tosoh Bioscience IncTosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotation drive motor on the AIA-900 Analyzer. If the tension of the timing belt between t
2018-09-28Tosoh Bioscience IncTosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If
2018-09-28Tosoh Bioscience IncTosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If
2018-09-28Tosoh Bioscience IncThere is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as intended and cause an insufficient volume of wash solution to be removed during th
2018-09-28Tosoh Bioscience IncA software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to be overwritten with the data from the 1st reagent bottle. Tosoh has released softw

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.