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

Recall Z-0148-2015 — siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro diagnostic test intended to measure phenytoin (dilantin, diphenylhydantoin), an anti-epileptic drug, in human serum and plasma. PTN test results are used in the diag

U.S. FDA — Device Enforcement · United States · 2014-09-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0148-2015
Date of alert: 2014-09-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics, Inc.
Product category: device
Product type: Devices

Reported risk: Internal testing has confirmed a low absorbance range between the levels 1 and 5 calibrators with this lot resulting in the potential for a positive or negative bias and imprecision across the PTN assay range.

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

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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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