Food, drugs, devices › Diagnostica Stago, Inc.
Device recall: STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59
FDA enforcement event 92007 is a device recall by Diagnostica Stago, Inc. of Parsippany, NJ, initiated 22 Mar 2023 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Diagnostica Stago, Inc. has 16 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Diagnostica Stago, Inc., Parsippany, NJ.
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)."
Distribution
"US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1575-2023 | STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026 | 6 analyzers | Class II | Ongoing | 17 May 2023 |
| Z-1576-2023 | STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612 | 2 analyers | Class II | Ongoing | 17 May 2023 |
| Z-1577-2023 | STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612 | 5 analyzers | Class II | Ongoing | 17 May 2023 |
Context
Other enforcement events for Diagnostica Stago, Inc.
All 16 events for Diagnostica Stago, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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)."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.