N Latex IgM — Class III medical device recall Z-1289-2015
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2015-03-25, distributed in CA, CO, FL, NC, NY, OH, UT. Complaints have been confirmed on failed proficiency testing due to serum samples recovering too low when usin
| Recall number | Z-1289-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Newark, DE, United States |
| Recall initiated | 2015-01-15 |
| Classified | 2015-03-17 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2016-08-17 |
| Distributed | CA, CO, FL, NC, NY, OH, UT |
| Countries outside the US | CA |
| Quantity | 26 |
| Lot numbers | 44018, 44019, 44042 |
| Model numbers | 44018, 44019, 44042, OQAC11 |
| Expiration dates | 2015-04-03 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1289-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.