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Siemens Healthcare Diagnostics, Inc. recalls N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) an
Recalled March 25, 2015 · FDA recall Z-1289-2015 · Siemens Healthcare Diagnostics
Hazard
Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019 and 44042. · FDA Class III
Units
26
Sold at
Worldwide Distribution: US distribution in states of: UT , CO, CA , FL , NY , OH , NC and country of : Canada.
Description
Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when using some N Latex IgM reagent kit lots 44018, 44019 and 44042.
Product
N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal fluid (CSF) and in paired CSF/serum samples by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec Systems. The determination of IgM aids in the evaluation of the patient's immune system.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →