Recall Z-1289-2015 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Mar 17, 2015 (initiated Jan 15, 2015) |
| Status | Terminated |
| 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. |
| 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 o |
| Quantity | 26 |
| Distribution | Worldwide Distribution: US distribution in states of: UT , CO, CA , FL , NY , OH , NC and country of : Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032014 | N LATEX IGM Dade Behring, Inc., Aug 7, 2003 |