Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 14, 2012
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Diagnostica Stago, Inc. recalled STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clin… - a moderate-severity action.
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clin… was recalled by Diagnostica Stago, Inc. in November 14, 2012. Reason: Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even …. Check the official notice for the remedy. Verify recall #Z-0252-2013 with the FDA Devices before acting.
The recall
Diagnostica Stago, Inc. issued this moderate-severity FDA Devices recall-Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even ….
- Moderate
- severity level
- 232 units
- affected scope
- Class II
- classification
- November 14, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0252-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0252-2013) was formally reported on November 14, 2012, with the manufacturer initiating the action on June 15, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Diagnostica Stago, Inc. is listed as the recalling firm, operating out of Parsippany, NJ. Federal records list the affected scope as 232 units US; 5 units Canada.
The documented reason for this recall is: Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printin… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Canada. 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
232 units US; 5 units Canada
Related Recalls
6
3 from same agency
Product description
STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
Reason for recall
Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite¿.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0252-2013 |
| Date reported | November 14, 2012 |
| Date initiated | June 15, 2012 |
| Recalling firm | Diagnostica Stago, Inc. |
| Firm location | Parsippany, NJ |
| Affected scope | 232 units US; 5 units Canada |
| Distribution | Worldwide Distribution - USA (nationwide) and Canada |
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-0252-2013) 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 Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.. Recalled by Diagnostica Stago, Inc.. Units affected: 232 units US; 5 units Canada.
Why was this product recalled? ▼
Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite¿.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2012. Severity: Moderate. Recall number: Z-0252-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) and Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0252-2013) 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 November 14, 2012. 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.