Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 25, 2020
Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer ver…
Compiled from official public sources by the editorial team.
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Siemens Healthcare Diagnostics, Inc. recalled Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to p… - a moderate-severity action.
Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to p… was recalled by Siemens Healthcare Diagnostics, Inc. in November 25, 2020. Reason: Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a…. Check the official notice for the remedy. Verify recall #Z-0474-2021 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a….
- Moderate
- severity level
- Class II
- classification
- November 25, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0474-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0474-2021) was formally reported on November 25, 2020, with the manufacturer initiating the action on October 26, 2020. 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 US: 214 units; OUS: 1082 units.
The documented reason for this recall is: Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently … Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republ…. 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 - 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 - 40,422 medical devices recalls on record
Where this recall sits in the database
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
US: 214 units; OUS: 1082 units
Related Recalls
6
0 from same agency
Product description
Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000
Reason for recall
Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0474-2021 |
| Date reported | November 25, 2020 |
| Date initiated | October 26, 2020 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Tarrytown, NY |
| Affected scope | US: 214 units; OUS: 1082 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominic… |
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-0474-2021) 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 IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11066000. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: US: 214 units; OUS: 1082 units.
Why was this product recalled? ▼
Test Definition scanning may reset custom settings to defaults. When a 2D Master Curve and TDef barcode for a new kit lot of reagent is scanned and the TDef version is a newer version than the version that is currently on the system, some of the customer defined settings for that assay may reset to default values
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2020. Severity: Moderate. Recall number: Z-0474-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cura¿ao, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Libya, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, P.R. China, Pakistan, Peru, Poland, Portugal, Qatar Republic, Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., 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-0474-2021) 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 November 25, 2020.
- 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 July 2026.