Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 21, 2016
RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turne…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics Inc recalled RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 104… - a moderate-severity action.
RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 104… was recalled by Siemens Healthcare Diagnostics Inc in September 21, 2016. Reason: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result d…. Check the official notice for the remedy. Verify recall #Z-2801-2016 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics Inc issued this moderate-severity FDA Devices recall-There is a potential for the first and/or last name of one patient to be printed with Patient ID and result d….
- Moderate
- severity level
- 197 units
- affected scope
- Class II
- classification
- September 21, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2801-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2801-2016) was formally reported on September 21, 2016, with the manufacturer initiating the action on August 11, 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 Norwood, MA. Federal records list the affected scope as 197 units.
The documented reason for this recall is: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system Distribution data in the federal record shows the product reached: Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech …. 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
197 units
Related Recalls
6
3 from same agency
Product description
RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
Reason for recall
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2801-2016 |
| Date reported | September 21, 2016 |
| Date initiated | August 11, 2016 |
| Recalling firm | Siemens Healthcare Diagnostics Inc |
| Firm location | Norwood, MA |
| Affected scope | 197 units |
| Distribution | Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark E… |
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-2801-2016) 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? ▼
RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393. Recalled by Siemens Healthcare Diagnostics Inc. Units affected: 197 units.
Why was this product recalled? ▼
There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 21, 2016. Severity: Moderate. Recall number: Z-2801-2016.
Where was the recalled product distributed? ▼
Distribution: Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Georgia Germany Greece Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Ivory Coast Japan Kazakhstan Kenya Kuwait Latvia Lebanon Lesotho Lithuania Luxembourg Macedonia Malaysia Mexico Netherlands New Caledonia New Zealand Norway P.R. China Peru Philippines Poland Portugal Qatar Rep. of Yemen Republic Korea Romania Russian Fed. Saudi Arabia Serbia Singapore Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Thailand Tunisia Turkey Turkmenistan U.A.E. 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-2801-2016) 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 September 21, 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.