Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1289-2015 — 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 patien

U.S. FDA — Device Enforcement · United States · 2015-01-15 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1289-2015
Date of alert: 2015-01-15
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Siemens Healthcare Diagnostics, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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