FDA Medical Device Recalls (openFDA)
Phadia US Inc: Phadia 1000 Instrument, Article Number 12-3800-01.
- Recall number
- Z-0387-2018
- Recalling firm
- Phadia US Inc
- Product
- Phadia 1000 Instrument, Article Number 12-3800-01.
- Status
- Terminated
- Initiated
- 2017-07-05
- Posted
- not on file
- Terminated
- 2018-10-04
- Reason
- The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.
- Root cause
- Device Design
- Action
- The firm sent letters with a return response form to customers. The firm instructed customers to immediately choose the "stop" command if presented with the 7-101 Liquid Sensor Error. Results from the assay should not be approved. A revision of the current software will have a mandatory installation soon.
- Quantity
- 70 units
- Distribution
- Nationwide
- Lot, serial or model codes
- All versions of the instrument
- 510(k) numbers
- ["K133404","K161899"]
- PMA numbers
- not on file
- Product code
- DHB
- Firm FEI
- 3004973408
- Firm city
- Portage
- Firm state
- MI
- 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