Z-2068-2011

Advanced Instrument Model 2020 Multi-Sample Osmometer Intended to measure the osmotic pressure of body fluids

Name: Z-2068-2011 Advanced Instrument Model 2020 Multi-Sample Osmometer Intended to measure the osmotic pressure of body fluids
Creator: Advanced Instruments, Inc.
Published: 2011-01-19
License: https://open.fda.gov/license/

Advanced Instruments, LLC / initiated 2011-01-19 / Terminated / root cause: manufacturing process

FDA source

Advanced Instruments, Inc. began a recall of Advanced Instrument Model 2020 Multi-Sample Osmometer Intended to measure the osmotic pressure of body fluids on 2011-01-19. The reason FDA records is "A poorly soldered power cord may pose a potential electrical shock hazard". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2068-2011
Status: Terminated
Initiated: 2011-01-19
Posted: 2011-04-26
Terminated: 2011-12-01
Recalling firm: Advanced Instruments, LLC
Product: Advanced Instrument Model 2020 Multi-Sample Osmometer Intended to measure the osmotic pressure of body fluids.
Product code: GKE Osmotic Fragility Testing
Reason for recall: A poorly soldered power cord may pose a potential electrical shock hazard.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Advanced 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 [email protected]. The attached response forms were to be completed and returned as instructed.
Quantity in commerce: 3 units
Distribution: Worldwide Distribution -- USA, including states of CA, GA IL, NJ, and MA and country of Belgium.
Product codes and lots: Serial Numbers: 10111986C, 10111987C, 10122019C, 10122020C, 10122021C, 10122022C, 10122029C, 10122030C

Product code GKE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)