FDA Medical Device Recalls (openFDA)
Phadia Ab: Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
- Recall number
- Z-2397-2019
- Recalling firm
- Phadia Ab
- Product
- Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
- Status
- Terminated
- Initiated
- 2019-07-09
- Posted
- not on file
- Terminated
- 2022-07-12
- Reason
- code 7-102 Liquid Sensor Error
- Root cause
- Under Investigation by firm
- Action
- The following actions are to be taken: 1. Use of the Phadia" 1000 can continue as detailed in the users manual with the following changes: If the error 7-102 occurs, ensure that the error is handled as stated below: A. Select Retry if the error occurs outside of Assay run. This selection has no effect on assay performance in this situation. B. Select Retry if the error occurred within Assay run in the previous six minutes. This selection has no effect on assay performance in this situation. Note: If you are unsure of the six minutes related to the error occurrence, select Stop. C. Select Stop if the error occurred within Assay run after six minutes as indicated in the system software. Note: Performing a Retry or Stop after six minutes presents a risk that assay performance and results are affected. Selecting Stop will stop ImmunoCAP dispensing and all processing tests will be flagged as erroneous. Corrective actions can then be performed. 2. Whether you select Retry or Stop, contact Technical Support after attending to error 7-102 according to the instructions above to provide notification to our technical department and to receive additional guidance. Additionally; Ensure that the sound alarm is audible and that the visible alarm is visible within the laboratory. Ensure that the criteria according to the user manual for incoming water (rinse solution) is met. Further, it is recommended to ensure that Monthly Maintenance with 1% Sodium Hypochlorite (bleach) solution is performed according to the user manual. Ensure Rinse and Wash Bottle Float/Stems are correctly installed in their respective bottles and are refilled in a timely manner when the instrument is operated. Ensure Stop Solution bottles are full at the start of Assay run, otherwise switch bottle connector to second bottle loaded prior to the first becoming empty. Note: Stop Solution bottles contain 1200 doses. If you have any questions, please
- Quantity
- 387 Instruments
- Distribution
- US Nationwide Distribution in the states of CA CO FL GA HI IL IN KS KY MA MD MI MO NC NJ NV NY OH OK OR PA TN TX UT VA WA
- Lot, serial or model codes
- All Serial Numbers; Unique Device Identifier (UDI): 07333066001005
- 510(k) numbers
- ["K051218"]
- PMA numbers
- not on file
- Product code
- DHB
- Firm FEI
- 3002807876
- Firm city
- Uppsala
- Firm state
- not on file
- Firm country
- Sweden
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