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QuikLYTE Dilution Check (2015-02-25) — recall 53405

Health Canada — Medical Devices · Canada · 2015-03-27 · Type III

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Agency: Health Canada — Medical Devices
Recall identifier: 53405
Date of alert: 2015-03-27
Country / jurisdiction: Canada
Risk level: Type III
Risk type: recall
Product category: Medical devices
Product type: Medical devices
Notice status: Archived by the issuing authority — kept for reference

Reported risk: Siemens Healthcare Diagnostics has confirmed complaints of failing dilution checks when using QuikLYTE dilution check Lot 4MD707. This lot may exhibit a positive bias possibly beyond 5% that can result in a dilution check failure or may result in an unnecessary correction if the bias is between 1 - 5%. A dilution check failure prevents complete installation of the QuikLYTE integrated multisensor as described in the dimension operator's guide.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/quiklyte-dilution-check-2015-0

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QuikLYTE Dilution Check (2015-02-25) — recall 53405

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