—#133400

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.

FDA product code: CFN — Method, Nephelometric, Immunoglobulins (G, A, M)
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K032014
Affected lot / code info: Catalog # OQAC11, lots 44018, 44019 and 44042, expiration 4/3/2015

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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: aydee.I.crawford@siemens.com or your local Siemens technical support representative.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

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

Timeline

Recall initiated: 2015-01-15
Posted by FDA: 2015-03-17
Terminated: 2016-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #133400. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.