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

Recall Z-1255-2015 — RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02

U.S. FDA — Device Enforcement · United States · 2014-12-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1255-2015
Date of alert: 2014-12-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Siemens Healthcare Diagnostics Inc
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10491395

Reported risk: Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.

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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