| Date Initiated by Firm | March 22, 2023 |
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| Date Posted | May 10, 2023 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1575-2023 |
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| Recall Event ID |
92007 |
| 510(K)Number | K151867 |
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| Product Classification |
System, multipurpose for in vitro coagulation studies - Product Code JPA
|
| Product | STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026 |
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| Code Information |
UDI-DI: 036074505901;
Serial Numbers: CP86010393
DB68093186
CP87010814
CP86070669
CP86090743
CP86090744
|
Recalling Firm/
Manufacturer |
Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
|
Manufacturer 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). |
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FDA Determined
Cause 2 | Device Design |
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| 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 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. |
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| Quantity in Commerce | 6 analyzers |
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| Distribution | US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = JPA
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