Recall archive
197 recalls · page 9 of 9
Reported Sep 12, 2012
syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless…
FDA (openFDA device enforcement)
Reported Sep 5, 2012
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details · Reason for recall — Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error…
FDA (openFDA device enforcement)
Reported Aug 29, 2012
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — When using the EasyLink Quality Control Package the system may not perform as intended for Multi-Rule QC violations [e.g., 2(2S), 4(1s) and 10x],…
FDA (openFDA device enforcement)
Reported Aug 15, 2012
EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classified as a data…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — There is a potential for the EasyLink system to display and transmit to the Laboratory Information System networks an incorrect result following the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 4, 2012
BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithrombin assay using the INNOVANCE(R) Antithrombin kit,…
1 more product in this recall
FDA (openFDA device enforcement)
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