Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 1, 2014
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash l…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics, Inc. recalled Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product … - a moderate-severity action.
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product … was recalled by Siemens Healthcare Diagnostics, Inc. in January 1, 2014. Reason: Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shi…. Check the official notice for the remedy. Verify recall #Z-0561-2014 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shi….
- Moderate
- severity level
- 18K units
- affected scope
- Class II
- classification
- January 1, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0561-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0561-2014) was formally reported on January 1, 2014, with the manufacturer initiating the action on May 6, 2013. 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 Newark, DE. Federal records list the affected scope as 17,719.
The documented reason for this recall is: Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, … Distribution data in the federal record shows the product reached: US Nationwide and OUS.. 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
17,719
Related Recalls
6
3 from same agency
Product description
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module
Reason for recall
Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected l
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0561-2014 |
| Date reported | January 1, 2014 |
| Date initiated | May 6, 2013 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Newark, DE |
| Affected scope | 17,719 |
| Distribution | US Nationwide and OUS. |
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-0561-2014) 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? ▼
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used in the Dimension(R) system with the heterogeneous module. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 17,719.
Why was this product recalled? ▼
Siemens Healthcare Diagnostics received complaints of Chemistry Wash causing QC and patient sample result shifts on CTN1, LTN1, FT4, TSH, PBNP and LPBN when using Chemistry Wash lots RD23031, RD23111, RD23241, RD23311, RD23391, and RD23461. These lots shipped between 12/12/2012 and 3/22/2013. Internal investigation has confirmed shifts can be encountered in two scenarios: 1 - When an affected l
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 1, 2014. Severity: Moderate. Recall number: Z-0561-2014.
Where was the recalled product distributed? ▼
Distribution: US Nationwide and OUS..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0561-2014) 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 January 1, 2014. 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.