CLASS II Device recall · Reported 15 Aug 2012 · FDA Enforcement Report
Siemens syngo(R) Lab Data Manager recalled
Siemens Healthcare Diagnostics is recalling Siemens syngo(R) Lab Data Manager, distributed nationwide in the US. The recall was initiated on 7 Jun 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2173-2012
- FDA event ID
- 62403
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jun 2012
- FDA classified
- 9 Aug 2012
- Reported
- 15 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 7 Jun 2012 | Recall initiated by company | |
| 9 Aug 2012 | Classified by FDA | +63 days |
| 15 Aug 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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
Where it was distributed
USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.
Nationwide ArizonaCaliforniaMissouriMississippiNorth CarolinaNew JerseyOhioOregonPennsylvaniaTexas
Questions about this recall
Is Siemens syngo(R) Lab Data Manager recalled?
Yes. Siemens Healthcare Diagnostics recalled Siemens syngo(R) Lab Data Manager on 7 Jun 2012. The recall is Class II and its status is Terminated. Recall number Z-2173-2012.
Why was it 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 lots are affected?
Version VA11B and all previously released versions.
Where was it sold?
USA (nationwide) including the states of AZ, CA, MS, MO, NJ, NC, OH, OR, PA, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Siemens Healthcare Diagnostics
All 694| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS III | Syva Emit Disopyramide Assay Enzyme Immunoassay recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Atellica CH Urine Albumin recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS III | Syva Emit tox Serum Tricyclic Antidepressant recalled | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |