CLASS II ONGOING Device recall · Reported 17 May 2023 · FDA Enforcement Report
STA Compact Automated Multi-Parametric Analyzer recalled
Diagnostica Stago is recalling STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612, distributed nationwide in the US. The recall was initiated on 22 Mar 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1576-2023
- FDA event ID
- 92007
- Recalling firm
- Diagnostica Stago, Parsippany, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Mar 2023
- FDA classified
- 10 May 2023
- Reported
- 17 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 22 Mar 2023 | Recall initiated by company | |
| 10 May 2023 | Classified by FDA | +49 days |
| 17 May 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Product as listed by the FDA
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Where it was distributed
US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
Nationwide IllinoisMassachusettsMinnesotaNebraskaTexasWisconsin
Questions about this recall
Is STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612 recalled?
Yes. Diagnostica Stago recalled STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612 on 22 Mar 2023. The recall is Class II and its status is Ongoing. Recall number Z-1576-2023.
Why was it recalled?
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).
Which lots are affected?
UDI-DI: 036074505860; Serial Numbers: 7096527 7116678
Where was it sold?
US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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