FDA Device recall Z-1289-2015
N Latex IgM
- FDA Device
- Class III
- terminated
- Published 2015-03-25
On 2015-03-25 the FDA classified a Class III recall of N Latex IgM by Siemens Healthcare Diagnostics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1289-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-01-15 |
| Published | 2015-03-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | CA, CO, FL, NC, NY, OH, UT |
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.
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.
Identifiers
| code_info | Catalog # OQAC11, lots 44018, 44019 and 44042, expiration 4/3/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1289-2015%22
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