Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1289-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class III

Date Initiated: January 15, 2015

Date Posted: March 25, 2015

Recall Number: Z-1289-2015

Event ID: 70385

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.

Status: Terminated

Product Quantity: 26

Code Information:

Catalog # OQAC11, lots 44018, 44019 and 44042, expiration 4/3/2015

Distribution Pattern:

Worldwide Distribution: US distribution in states of: UT , CO, CA , FL , NY , OH , NC and country of : Canada.

Voluntary or Mandated:

Voluntary: Firm initiated