Health Products

UniCel DxI 600 & 800 Systems

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Chemistry
Product: UniCel DxI 600 & 800 Systems
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalog number
UniCel DxI 600 Access Immunoassay Analyzer902386A30260
UniCel DxI 600 Access Immunoassay Analyzer902624A30260
UniCel DxI 600 Access Immunoassay Analyzer902385A30260
UniCel DxI 600 Access Immunoassay Analyzer902622A30260
UniCel DxI 600 Access Immunoassay Analyzer902475A30260
DxI 600 Access Immunoassay W/Spot BMore than 10 numbers, contact manufacturer.A71460
UniCel DxI 800 Access Immunoassay Analyzer609576973100

Issue

Beckman identified an issue on UniCel DxI 600 & 800 Systems with linear slide pnp gantries running software versions 5.7 and up. During installs or upgrades, the Beckman identified an issue on UniCel DxI 600 & 800 Systems with linear slide pnp gantries running software versions 5.7 and up. During installs or upgrades, the pnp xmotor current incorrectly resets to 1.5a (instead of the required 2.0a) because the software overwrites the factory setting, causing increased pnp motion errors. current incorrectly resets to 1.5a (instead of the required 2.0a) because the software overwrites the factory setting, causing increased pnp motion errors. Recall start date: June 18, 2025

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