Z-1289-2015Class III

N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal...

Name: Z-1289-2015 N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebrospinal...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2015-01-15
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-01-15 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of 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... on 2015-01-15. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1289-2015
Classification: Class III
Status: Terminated
Initiated: 2015-01-15
Posted: 2015-03-17
Terminated: 2016-08-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CFN Method, Nephelometric, Immunoglobulins (G, A, M)
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Siemens, sent an "Urgent Medical Device Recall" letter dated January 2015 to its customers on January 13, 2015. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Discontinue use of the affected lots and discard any remaining material; Identify if IgM quotient was overestimated due to falsely low IgM results with serum sample; Reconsider patient diagnosis taking other patient data into consideration.; When other patient data does not support the result for an intrathecal IgM synthesis or inflammation, re-measurement of samples may be considered using and alternative lot. In addition, Siemens requested customers to review this letter with their Medical Director; to complete and return the attached Effectiveness Check/Product Replacement form via fax to Customer Care Center at (312) 275-7795; retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Customer Care Center 800-441-9250 or email: [email protected] or your local Siemens technical support representative.
Quantity in commerce: 26
Distribution: Worldwide Distribution: US distribution in states of: UT , CO, CA , FL , NY , OH , NC and country of : Canada.
Product codes and lots: Catalog # OQAC11, lots 44018, 44019 and 44042, expiration 4/3/2015

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1289-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1289-2015	Class III	Terminated	Voluntary: Firm initiated	2015-03-25	2015-03-17

Product code CFN

K032014Class IIN Latex IgmDade Behring, Inc. / cleared 2003-08-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)