FDA Enforcement
Class III
Terminated
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.
Recall: Z-1289-2015
·
Reported March 25, 2015
Enforcement
- Recall Number
- Z-1289-2015
- Event ID
- 70385
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Healthcare Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 25, 2015
- Initiation Date
- January 15, 2015
- Classification Date
- March 17, 2015
- Termination Date
- August 17, 2016
- Address
- 500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, 19702-2466, United States
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.
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 Info
Catalog # OQAC11, lots 44018, 44019 and 44042, expiration 4/3/2015
Distribution
Worldwide Distribution: US distribution in states of: UT , CO, CA , FL , NY , OH , NC and country of : Canada.
Quantity
26