Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported July 14, 2021
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics, Inc. recalled Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of cli… - a moderate-severity action.
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of cli… was recalled by Siemens Healthcare Diagnostics, Inc. in July 14, 2021. Reason: Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction…. Check the official notice for the remedy. Verify recall #Z-2026-2021 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction….
- Moderate
- severity level
- Class II
- classification
- July 14, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2026-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2026-2021) was formally reported on July 14, 2021, with the manufacturer initiating the action on May 13, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of Tarrytown, NY. Federal records list the affected scope as US: 210 OUS: 874.
The documented reason for this recall is: Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a ris… Distribution data in the federal record shows the product reached: Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Cura¿ao Cyprus Czech Republic Denmark Ecuad…. 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, 6 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 - 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
US: 210 OUS: 874
Related Recalls
6
6 from same agency
Product description
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000
Reason for recall
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2026-2021 |
| Date reported | July 14, 2021 |
| Date initiated | May 13, 2021 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Tarrytown, NY |
| Affected scope | US: 210 OUS: 874 |
| Distribution | Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Cura¿ao Cyprus Czech Republic Denmark Ecuador Egypt Estonia … |
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-2026-2021) 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? ▼
Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: US: 210 OUS: 874.
Why was this product recalled? ▼
Valves used on the Atellica CH 930, Atellica IM 1300 and Atellica IM 1600 analyzers may develop a malfunction due to a manufacturing defect and may result in the valve wearing and leaking over time. The leaking is a risk in valves subject to high pressure or high wear and may impact the result accuracy of any assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 14, 2021. Severity: Moderate. Recall number: Z-2026-2021.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: Country Name Algeria Argentina Australia Austria Bahrain Bangladesh Belgium Brazil Bulgaria Burkina Faso Canada Chile Colombia Croatia Cura¿ao Cyprus Czech Republic Denmark Ecuador Egypt Estonia Finland France Germany Greece Hungary India Indonesia Iraq Ireland Israel Italy Japan Kenya Kuwait Latvia Libya Lithuania Malaysia Mexico Morocco Netherlands New Zealand Norway Oman P.R. China Pakistan Peru Philippines Poland Portugal Qatar Republic Korea Romania Russian Fed. Saudi Arabia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey U.A.E. Uganda Ukraine United Kingdom Uruguay Vatikancity Vietnam.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2026-2021) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported July 14, 2021.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. 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 June 2026.