Recall Z-1576-2023 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Diagnostica Stago, Inc.
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
| Date | May 10, 2023 (initiated Mar 22, 2023) |
| Status | Open, Classified |
| 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 Cu |
| Quantity | 2 analyers |
| Distribution | US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093167 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER Diagnostica Stago, Inc., Dec 22, 2009 |