Recall Z-1289-2015— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1289-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-15

Class III · Terminated

Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2015-01-15, terminated 2016-08-17. It names one FDA 510(k) clearance: K032014. 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.. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class III
Status: Terminated
Initiated: 2015-01-15
Terminated: 2016-08-17
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K032014 — N LATEX IGMDade Behring, Inc.·cleared 2003-08-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.