Bath, Incubators/water, All
Microbiology · 21 CFR 866.2540
Recent MDR events
28 adverse event reports on file
- BD KIESTRA READA COMPACTJun 17, 2025MalfunctionBd Kiestra Lab Automation3010141591-2025-00002
- COMPACT WATER BATHJan 7, 2025MalfunctionSynthes Gmbh8030965-2025-00171
- BD KIESTRA READA COMPACTApr 16, 2023MalfunctionBd Kiestra Lab Automation3010141591-2023-00002
- COMPACT WATER BATHDec 17, 2020InjuryWrights Lane Synthes Usa Products Llc2939274-2020-05629
- COMPACT WATER BATHFeb 6, 2020MalfunctionOberdorf Synthes Produktions Gmbh8030965-2020-00907
- WATER BATH HEATERJan 24, 2019MalfunctionWrights Lane Synthes Usa Products Llc2939274-2019-56054
- COMPACT WATER BATHJan 16, 2019InjuryOberdorf Synthes Produktions Gmbh8030965-2019-59957
- WATER BATH STERILITY COVERJun 8, 2016MalfunctionSynthes Usa2520274-2016-13071
- BD KIESTRA¿ READA COMPACTNov 25, 2015MalfunctionBd Kiestra Lab Automation3010141591-2015-00003
- BD KIESTRA¿ READA COMPACTNov 25, 2015MalfunctionBd Kiestra Lab Automation3010141591-2015-00004
Event type breakdown
Recalls
11 recall events for this product code
- BD KIESTRA LAB AUTOMATIONOpen, ClassifiedMar 27, 2026
BD Kiestra" ReadA;
In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity.
Z-1658-2026 · View FDA record ↗ - Thermo Fisher Scientific (Asheville) LLCTerminatedApr 10, 2013
CO2 Incubators (General Purpose Incubator), model numbers 370, 371, 380, 381, 3307, 3308, 3310, 3311, 3540, 3541, 3542, 3543, 3584, 3585, 3598, and 3599.
Incubators manufactured prior to mid 2009 have coated metal hinges that have reportedly failed in the field.
Z-1079-2013 · View FDA record ↗ - Thermo Fisher Scientific (Asheville) LLCTerminatedUnknown
Fisher Scientific Isotemp -General Purpose Water Bath:
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Z-1865-2019 · View FDA record ↗ - Thermo Fisher Scientific (Asheville) LLCTerminatedUnknown
Fisher Scientific Isotemp -General Purpose Water Bath:
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Z-1866-2019 · View FDA record ↗ - Thermo Fisher Scientific (Asheville) LLCTerminatedUnknown
Fisher Scientific Isotemp -General Purpose Water Bath:
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Z-1867-2019 · View FDA record ↗ - Thermo Fisher Scientific (Asheville) LLCTerminatedUnknown
Thermo Scientific General Purpose Dynamic Bath
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Z-1868-2019 · View FDA record ↗ - Thermo Fisher Scientific (Asheville) LLCTerminatedUnknown
Thermo Scientific General Purpose Dynamic Bath
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Z-1869-2019 · View FDA record ↗ - Thermo Fisher Scientific (Asheville) LLCTerminatedUnknown
Thermo Scientific General Purpose Dynamic Bath
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Z-1870-2019 · View FDA record ↗ - Thermo Fisher Scientific (Asheville) LLCTerminatedUnknown
Thermo Scientific General Purpose Dynamic Bath
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Z-1871-2019 · View FDA record ↗ - Thermo Fisher Scientific (Asheville) LLCTerminatedUnknown
Thermo Scientific General Purpose Dynamic Bath
Product may have been assembled incorrectly,the assembly error can cause the bath to malfunction and raise the temperature of the fluid in the reservoir above the temperature set point selected by the user.
Z-1872-2019 · View FDA record ↗
Registered firms
55 firms currently registered for this product code
Synthes (usa) Products Llc
West Chester, PA, US
Hager Worldwide, Inc.
Hickory, NC, US
Emsere, Inc.
Peachtree City, GA, US
Scitek Global Co.,ltd
Jinan Shandong, CN
Digisystem Laboratory Instruments Inc.
New Taipei City, TW
Benchmark Electronics, Inc.
WINONA, MN, US
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
Nuve Sanayi Malzemeleri Imalat Ve Ticaret A.s.
ANKARA, TR
Exact Sciences Corporation- Innovation Campus
Madison, WI, US
Lw Scientific, Inc.
LAWRENCEVILLE, GA, US
Domel, D.o.o., (business Unit Labs)
Zelezniki, SI
Remi Elektrotechnik Ltd.
Dist. Palghar Maharashtra, IN
Scigene
Santa Clara, CA, US
Exact Sciences Corporation- Discovery Campus
Madison, WI, US
Biobase Biodustry(shandong)co., Ltd
Jinan Shandong, CN
Agilent Technologies, Inc.
Winooski, VT, US
Hefei Mt Medical Co.,ltd.
Hefei Anhui, CN
Thermo Fisher Scientific (asheville) Llc
MARIETTA, OH, US
Depuy Orthopaedics
BRIDGEWATER, MA, US
Yantai Addcare Bio-tech Co., Ltd.
Yantai Shandong, CN
Infitek Co., Ltd.
Shanghai, CN
Grifols Diagnostic Solutions Inc.
SAN DIEGO, CA, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
High Technology, Inc.
North Attleboro, MA, US
Qingdao Haier Biomedical Technology Co Ltd
Qingdao Shandong, CN
510(k) clearances
12 clearances for this product code
- Sterling Drug, Inc.Jan 27, 1988
K875275 · WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER
- Scientific Sales Intl., Inc.Sep 3, 1985
K853379 · PLATE INCUBATOR
- Boekel Industries, Inc.Jun 16, 1983
K831592 · ANHYDRIC INCUBATORS, CULTURE INCUBATOR
- Remel Co.Mar 28, 1983
K830322 · C.A.T. REAGENT KIT
- Bionetic Laboratory ProductsMar 10, 1983
K830227 · AUTOMATED ELISA READER LBI 300
- Bionetic Laboratory ProductsMar 10, 1983
K830405 · LBI-100 37DEGREES INCUBATOR
- Boekel Industries, Inc.Sep 14, 1982
K822564 · WATER BATH
- Forma Scientific, Inc.Oct 23, 1981
K812826 · FORMA CH/P GAS PROCESSOR