Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 27, 2016
ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should
Eight (8) issues were identified which may affect the results generated by the system software version.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics, Inc. recalled ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 … - a moderate-severity action.
ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 … was recalled by Siemens Healthcare Diagnostics, Inc. in July 27, 2016. Reason: Eight (8) issues were identified which may affect the results generated by the system software version.. Check the official notice for the remedy. Verify recall #Z-2256-2016 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Eight (8) issues were identified which may affect the results generated by the system software version..
- Moderate
- severity level
- 446 units
- affected scope
- Class II
- classification
- July 27, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2256-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2256-2016) was formally reported on July 27, 2016, with the manufacturer initiating the action on May 26, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of Tarrytown, NY. Federal records list the affected scope as 446 units Total (3 domestically & 443 internationally).
The documented reason for this recall is: Eight (8) issues were identified which may affect the results generated by the system software version. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of MD, MN, MS and the countries of Australia, Austria, Bangladesh, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guadelou…. 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
446 units Total (3 domestically & 443 internationally)
Related Recalls
6
3 from same agency
Product description
ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
Reason for recall
Eight (8) issues were identified which may affect the results generated by the system software version.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2256-2016 |
| Date reported | July 27, 2016 |
| Date initiated | May 26, 2016 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Tarrytown, NY |
| Affected scope | 446 units Total (3 domestically & 443 internationally) |
| Distribution | Worldwide Distribution - US Nationwide in the states of MD, MN, MS and the countries of Australia, Austria, Bangladesh, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guadeloupe, Hong Kong, Hunga… |
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-2256-2016) 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? ▼
ADVIA¿ Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.1086 SMN 11219806), V1.0.3 (Bundle 1.0.1108 SMN 11220781) and V1.1 (Bundle 1.1.243 SMN 11221979). Product Usage: This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 446 units Total (3 domestically & 443 internationally).
Why was this product recalled? ▼
Eight (8) issues were identified which may affect the results generated by the system software version.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 27, 2016. Severity: Moderate. Recall number: Z-2256-2016.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the states of MD, MN, MS and the countries of Australia, Austria, Bangladesh, Belgium, Canada, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Guadeloupe, Hong Kong, Hungary, India, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Netherlands, New Zealand, Norway, P.R. China, Philippines, Poland, Portugal, Qatar, Republic Korea, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E, United Kingdom & Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2256-2016) 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 July 27, 2016. 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.