Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 15, 2012
Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics, Inc. recalled Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a da… - a moderate-severity action.
Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a da… was recalled by Siemens Healthcare Diagnostics, Inc. in August 15, 2012. Reason: The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with th…. Check the official notice for the remedy. Verify recall #Z-2173-2012 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall-The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with th….
- Moderate
- severity level
- 15 units
- affected scope
- Class II
- classification
- August 15, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2173-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2173-2012) was formally reported on August 15, 2012, with the manufacturer initiating the action on June 7, 2012. 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 15.
The documented reason for this recall is: The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the … Distribution data in the federal record shows the product reached: USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.. 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
15
Related Recalls
6
3 from same agency
Product description
Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments
Reason for recall
The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the LIS an incorrect result following the syngo LDM's application of the configured result number format. The problem is encountered when the result number format configured on the Sys
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2173-2012 |
| Date reported | August 15, 2012 |
| Date initiated | June 7, 2012 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | Newark, DE |
| Affected scope | 15 |
| Distribution | USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX. |
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-2173-2012) 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? ▼
Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 15.
Why was this product recalled? ▼
The recalling firm has discovered that when using a Sysmex(R) CA-7000 or CA-1500 coagulation analyzer with the syngo Lab Data Manager (LDM), there is a potential for the syngo LDM system, to display and transmit to the LIS an incorrect result following the syngo LDM's application of the configured result number format. The problem is encountered when the result number format configured on the Sys
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 15, 2012. Severity: Moderate. Recall number: Z-2173-2012.
Where was the recalled product distributed? ▼
Distribution: USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2173-2012) 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 August 15, 2012. 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.