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

RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN)… — recall Z-2803-2016

U.S. FDA — Device Enforcement · United States · 2016-08-11 · Class II

As described by U.S. FDA — Device Enforcement: RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked on this page. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2803-2016
Date of alert
2016-08-11
Country / jurisdiction
United States
Risk level
Class II
Notice type
recall
Brand
Siemens Healthcare Diagnostics Inc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Foreign: Albania Algeria Angola Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bosnia Herzeg. Botswana Brazil Brunei Bulgaria Canada Chile Colombia Croatia Czech Republic Denmark Ecuador Egypt Estonia Finland France Fren.Polynesia Geor
Reported risk: There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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