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U.S. Department of Health and Human Services

Class 2 Device Recall Advanced Instrument Model 2020 MultiSample Osmometer

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 Class 2 Device Recall Advanced Instrument Model 2020 MultiSample Osmometersee related information
Date Initiated by FirmJanuary 19, 2011
Date PostedApril 26, 2011
Recall Status1 Terminated 3 on December 01, 2011
Recall NumberZ-2068-2011
Recall Event ID 58042
Product Classification Osmotic Fragility Testing - Product Code GKE
ProductAdvanced Instrument Model 2020 Multi-Sample Osmometer Intended to measure the osmotic pressure of body fluids.
Code Information Serial Numbers: 10111986C, 10111987C, 10122019C, 10122020C, 10122021C, 10122022C, 10122029C, 10122030C 
FEI Number 1217058
Recalling Firm/
Manufacturer		 Advanced Instruments, Inc.
Two Technology Way
Norwood MA 02062-2633
For Additional Information ContactSAME
781-320-9000
Manufacturer Reason
for Recall		A poorly soldered power cord may pose a potential electrical shock hazard.
FDA Determined
Cause 2		Employee error
ActionAdvanced Instruments Product Service Department contacted each customer on 1/19/11 via an Urgent Product Recall Notice. The letter identified the reason for recall along with the affected products. The letter provided instructions to safely examine the date code of the AC Power Inlet assembly on the affected product. If customers were unable to perform the inspection or had questions concerning the instructions, they were to contact Advanced Instruments Product Service Manager at 781-471-2147 or via email jorges@aicompanies.com. The attached response forms were to be completed and returned as instructed.
Quantity in Commerce3 units
DistributionWorldwide Distribution -- USA, including states of CA, GA IL, NJ, and MA and country of Belgium.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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