STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Summary
The FDA issued a Class II for STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 586 by Diagnostica Stago, Inc.. Reason: An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increa.
Details
Source
Device Recall
External ID
Z-1576-2023
Action Date
2023-05-17
Status
Ongoing
Category
device
Product Description
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
Lot/Code Info: UDI-DI: 036074505860; Serial Numbers: 7096527 7116678
Quantity Affected: 2 analyers
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-22
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 160 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Diagnostica Stago, Inc. has 13 FDA actions in our database, including 12 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Diagnostica Stago, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Diagnostica Stago, Inc. have FDA actions?
Diagnostica Stago, Inc. has 13 FDA actions in our database, including 12 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1576-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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