Z-0545-2007

Sample Management System software for in vitro diagnostic testing Product # 030102-03

Name: Z-0545-2007 Sample Management System software for in vitro diagnostic testing Product # 030102-03
Creator: Siemens Medical Solutions Diagnostics
Published: 2007-01-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2007-01-15 / Terminated

FDA source

Siemens Medical Solutions Diagnostics began a recall of Sample Management System software for in vitro diagnostic testing Product # 030102-03 on 2007-01-15. The reason FDA records is "Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0545-2007
Status: Terminated
Initiated: 2007-01-15
Posted: 2007-03-01
Terminated: 2008-01-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Sample Management System software for in vitro diagnostic testing Product # 030102-03
Product code: CDD Radioassay, Vitamin B12
Reason for recall: Under limited circumstances, an incorrect patient result could be printed on the optional chartable patient report.
FDA root cause: Other
Action: A recall communication was sent on 1/15/2007 to all customers by fax.
Quantity in commerce: 87 units
Distribution: Worldwide, including USA, Australia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, UAE and United Kingdom.
Product codes and lots: SMS Product # 030102-03, Serial #s D0314, D0280, E0545, C0081, C0026, D0384, D0244, E0515, E0511, E0550, C0222, C0223, C0207, D0355, E0517, C0219R,C0221, B0021, B0022, D0353, E0503, E0446, C0193, E0471, E0566, D0299, E0513, D0281, D0356, C0101, C0203, C0205, B0027, E0426, E0440, C0176, C0182, E0504, C0220, E0495, D0272, E0490, E0534, C0208, C0218, C0191, E0473, D0296, C0168, E0470, C0199, D0330, C0206, D0313, C0192, E0509, D0369, E0492, E0493, D0304, D0310, D0311, E0563, D0331, C0204, E0589, D0327, D0275, E0514, E0443, E0444, D0243, C0216, C0217, E0546, E0548, C0209, E0450, D0291, D0276, D0273, D0332, E0508, B0033, E0449, E0516, D0357

Product code CDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)