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

RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RA — recall Z-2079-2014

U.S. FDA — Device Enforcement · United States · 2014-05-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2079-2014
Date of alert: 2014-05-23
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): 2334500011

Reported risk: RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-)

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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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