FDA-Device2015-03-25Class III
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.
Siemens Healthcare Diagnostics, Inc.
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.
Sold states
Worldwide Distribution: US distribution in states of: UT , CO, CA , FL , NY , OH , NC and country of : Canada.
Affected count
26
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1289-2015Don't want to check this manually?
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