FDA Medical Device Recalls (openFDA)
Advanced Instruments, Inc.: Advanced Instrument Model 2020 Multi-Sample Osmometer Intended to measure the osmotic pressure of body fluids.
- Recall number
- Z-2068-2011
- Recalling firm
- Advanced Instruments, Inc.
- Product
- Advanced Instrument Model 2020 Multi-Sample Osmometer Intended to measure the osmotic pressure of body fluids.
- Status
- Terminated
- Initiated
- 2011-01-19
- Posted
- 2011-04-26
- Terminated
- 2011-12-01
- Reason
- A poorly soldered power cord may pose a potential electrical shock hazard.
- 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 jorges@aicompanies.com. The attached response forms were to be completed and returned as instructed.
- Quantity
- 3 units
- Distribution
- Worldwide Distribution -- USA, including states of CA, GA IL, NJ, and MA and country of Belgium.
- Lot, serial or model codes
- Serial Numbers: 10111986C, 10111987C, 10122019C, 10122020C, 10122021C, 10122022C, 10122029C, 10122030C
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GKE
- Firm FEI
- 1217058
- Firm city
- Norwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28