Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 17, 2023
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence o…
Diagnostica Stago, Inc. recalled STA R Max fully automatic clinical instrument designed to perform tests on human plasmas,… - a moderate-severity action.
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas,… was recalled by Diagnostica Stago, Inc. in May 17, 2023. Reason: An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent …. Check the official notice for the remedy. Verify recall #Z-1575-2023 with the FDA Devices before acting.
The recall
Diagnostica Stago, Inc. issued this moderate-severity FDA Devices recall-An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent ….
- Moderate
- severity level
- Class II
- classification
- May 17, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1575-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1575-2023) was formally reported on May 17, 2023, with the manufacturer initiating the action on March 22, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Diagnostica Stago, Inc. is listed as the recalling firm, operating out of Parsippany, NJ. Federal records list the affected scope as 6 analyzers.
The documented reason for this recall is: 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 anal… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
6 analyzers
Related Recalls
6
3 from same agency
Product description
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
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).
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1575-2023 |
| Date reported | May 17, 2023 |
| Date initiated | March 22, 2023 |
| Recalling firm | Diagnostica Stago, Inc. |
| Firm location | Parsippany, NJ |
| Affected scope | 6 analyzers |
| Distribution | US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1575-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026. Recalled by Diagnostica Stago, Inc.. Units affected: 6 analyzers.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on May 17, 2023. Severity: Moderate. Recall number: Z-1575-2023.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of IL, MA, MN, NE, TX, and WI..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1575-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 17, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.