FDA Medical Device Recalls (openFDA)
Diagnostica Stago, Inc.: STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
- Recall number
- Z-1576-2023
- Recalling firm
- Diagnostica Stago, Inc.
- Product
- STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
- Status
- Open, Classified
- Initiated
- 2023-03-22
- Posted
- 2023-05-10
- Terminated
- not on file
- Reason
- An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).
- Root cause
- Device Design
- Action
- Customers were contacted via telephone and an URGENT: MEDICAL DEVICE CORRECTION notification letter beginning 3/22/23. Actions: Stago downgraded your firmware to the previous firmware version as a precaution. Your downgrade has already occurred. Consequently, the risk of this bug only existed during the time period shown above (i.e. from new firmware installation date to the downgrade date). As patient results are interpreted in association with other biological tests, we leave the decision to review previous patient results based on the complete clinical context to your discretion. Our Customer Service team is available to help you carry out your impact analysis. For additional information, please contact your Stago Hotline at 1-800-725-0607.
- Quantity
- 2 analyers
- Distribution
- US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
- Lot, serial or model codes
- UDI-DI: 036074505860; Serial Numbers: 7096527 7116678
- 510(k) numbers
- ["K093167"]
- PMA numbers
- not on file
- Product code
- JPA
- Firm FEI
- 2245451
- Firm city
- Parsippany
- Firm state
- NJ
- 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