STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
FDA device recall Z-1576-2023 · posted 2023-05-10 · Open, Classified
Recall details
- Recalling firm
- Diagnostica Stago, Inc.
- Reason for recall
- 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).
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- JPA
- Quantity affected
- 2 analyers
- Distribution
- US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
- Date initiated
- 2023-03-22
- Date posted
- 2023-05-10
- Location
- Parsippany, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER (K093167) | Diagnostica Stago, Inc. | 2009-12-22 |