Device 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.
Z-1289-2015
Product summary
- Event
- Event 70385
- Status
- Terminated
- Classification
- Class III
- Quantity
- 26
- Official record key
device-enforcement:Z-1289-2015
Official wording
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.
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.
Derived failure modes
-
Unknown
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.