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U.S. Department of Health and Human Services

Class 2 Device Recall STATION, PIPETTING AND DILUTING, FOR CLINICAL USE

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 Class 2 Device Recall STATION, PIPETTING AND DILUTING, FOR CLINICAL USEsee related information
Date Initiated by FirmJanuary 15, 2021
Create DateFebruary 27, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1156-2021
Recall Event ID 87219
Product Classification Station, pipetting and diluting, for clinical use - Product Code JQW
ProductHAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400
Code Information Various Part Numbers: Hamilton Company PART NUMBER/ DESCRIPTION 188318/ HHS2,2MM ORBIT,CUSTOMIZED; 188319/ HHS2,3MM ORBIT,CUSTOMIZED; 199000/ HHS 0.5 MTP FLAT BOTTOM; 199001/ HHS 2.0 MTP FLAT BOTTOM; 199002/ PLEASE USE PN: 199034; 199007/ HHS 2.0 NUNC DWP 96 2ML; 199008/ HHS 3.0 NUNC DWP 96 2ML; 199009/ HHS 1.5 MTP FLAT BOTTOM; 199011/ HHS,1.5MM,NUNC,96DWP,2ML; 199027/ HHS 1.5 MM SARSTEDT 48X1.5ML; 199033/ HHS2,2MM ORBIT,MTP FLT BOTTOM; 199034/ HHS2,3MM ORBIT,MTP FLT BOTTOM; 199037/ HHS 1.5MM NUNC DWP 96 2ML; 199038/ HHS2,2MM ORBIT,NUNC DWP96 2M; 199039/ HHS2,3MM ORBIT,NUNC DWP96 2M; 199085/ HHS 3.0 FLIPTUBE RACK; 199474/ HHS 3.0 BIO-RAD DWP FSD; 809018/ HHS 3.0 AUTOLYS; 0201710-001/ HHSADVWR40002-012DWP96CON2ML; 0202697-002/ HHS,RGT TRUGH HOLD FRAME,LID; 0203408-002/ HHS,199034; 188219APE/ HHS 3.0MM AMPLITUDE; 199033R/ HHS2,2MM ORBIT,MTP FLT BOT REF; 199034R/ HHS2,3MM ORBIT,MTP FLT BTM; 65608-01/ HHS2,3MM ORBIT, MPT; 65608-01R/ HHS2,3MM ORBIT, MPT,REFURB; 6601885-01/ KIT,HHS,3 MM ORBIT,ML PREP; 6601885-02/ KIT,HHS,2 MM ORBIT,ML PREP; 95379-01/ HHS2,3MM ORBIT,DWP96,EXACT SCI;  Hamilton Bonaduz AG PART NUMBER DESCRIPTION 188319/ Hamilton Heater Shaker, flat bottom adapter (APE); 199033/ Hamilton Heater Shaker, flat bottom adapter; 199034/ Hamilton Heater Shaker, flat bottom adapter; 199037/ HHS 1.5 NUNC DWP 96 2ML; 199038/ HHS 2.0 NUNC DWP 96 2ML; 199039/ Hamilton Heater Shaker 3.0 Nunc DWP; 199068/ HHS 1.5 ROCHE; 199474/ HHS 3.0mm BIO-RAD FSD; 199525/ HHS 2.0 MTP V BOTTOM; 809018/ HHS 3.0 AUTOLYS; 816040/ HHS 1.5mm 2G; 816061/ HHS 1.5 NUNC DWP 96 2ML TIG; 819273/ HHS 3.0 V-BOTTOM; 10069018/ HHS 3.0 NUNC DWP 96 2ML TIG  
FEI Number 2915796
Recalling Firm/
Manufacturer		 Hamilton Co
4970 Energy Way
Reno NV 89502-4123
For Additional Information ContactTim Zavora
775-858-3000
Manufacturer Reason
for Recall		There is a risk that the device can start a fire if flammable liquids contact and enter the device.
FDA Determined
Cause 2		Device Design
ActionAn URGENT: MEDICAL DEVICE CORRECTION notifications was sent to the consignees via email of 01/15/2021. Hamilton Heater Shaker upgrades were started on 15-JAN- 2021. A device upgrade has been developed to mitigate the risk of the device catching fire. The upgrade consists of a plastic tray within the body of the Hamilton Heater Shaker and a redesigned base plate. These upgrades prevent liquid from reaching the electrical components of the device. The recall notification states: " Hamilton Company Field Service will contact your organization to schedule a time to upgrade your Hamilton Heater Shaker(s) to mitigate this risk. For customers who perform their own field service, a zero-dollar purchase order can be submitted to RoboticsOEMsales@hamiltoncompany .com to obtain upgrade kits. The upgrade consists of a plastic tray within the body of the Hamilton Heater Shaker and a redesigned base plate. These upgrades prevent liquid from reaching the electrical components of the device. This upgrade will be supplied free-of-charge and does not impact the functionality of the device. Until the upgrade is performed, it is crucial to observe the following safety best practices: o Methods should include labware touch-off presence checks to ensure the labware is ready to receive liquid. o On-deck waste and fluid collection devices should be placed at least one track away from Hamilton Heater Shakers or any other heating device. Recipients of this notice shall forward it to all customers to whom they have sold Hamilton Heater Shakers. Please complete and return the attached Acknowledgement and Receipt Form to productrecalls@hamiltoncompany.com . On this form, please indicate if you have experienced a fire on your device. If you experience a fire on your device in the future, please notify your Hamilton representative immediately and cease using the device. Please contact productrecalls@hamiltoncompany.com or call 800-527-5269 between 7:00am and 3:30pm P
Quantity in Commerce4729 units
DistributionUS - AL, AR, AZ, CA, CO, CT, DC. DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA. MD, ME. MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI AND WY OUS - AUSTRALIA, AUSTRIA, BRAZIL , CANADA , CHILE, CHINA, , COLOMBIA , FINLAND , GERMANY , ITALY , JAPAN , JPN , KOREA, SOUTH, PARAGUAY , PERU , PHL , ROMANIA , ROU , SINGAPORE, SWITZERLAND , SWITZERLAND , THAILAND, TWN , UNITED KINGDOM, AND URUGUAY
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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