Recall Monitor
Health Products

DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Get told about the next health product recall.

We email or text you when Canada issues a recall that matches what you watch: a brand, a product, an allergen. Most never make the news.

Get health product recall alerts

CA$3.99/mo · cancel anytime

Products

Affected productsLot or serial numberModel or catalogue number
DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay ModuleMore than 10 numbers, contact manufacturer.C11137
DxI 9000 Access Immunoassay AnalyzerMore than 10 numbers, contact manufacturer.C13252

Issue

Beckman Coulter has confirmed a software anomaly on the DxC 500i Clinical Analyzer and DxI 9000 Access Immunoassay Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results (R1, R2) and potential delays in reporting (R3), risking erroneous diagnoses if undetected

Get told about the next health product recall.
Get health product recall alerts

CA$3.99/mo · cancel anytime