DxI 800 immunoassay analyzer motor current resets below the required setting
A DxI 800 Access Immunoassay Analyzer is being recalled because software overwrites the factory PnP X-motor current setting, causing increased motion errors that could delay patient results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall where the stated consequence is a delay in reporting results rather than an incorrect patient result.
Plain-English summary
The DxI 800 Access Immunoassay Analyzer with Dual Gantry, part number A71457, UDI-DI 15099590369231, serial number 608109, is being recalled. The action covers 1 system.
According to Beckman Coulter, UniCel DxI 600/800 systems with linear slide PnP gantries running software versions 5.7 and up faced incorrect PnP X-motor current settings, where the current incorrectly resets to 1.5A instead of the required 2.0A because the software overwrites the factory setting during installs or upgrades. The manufacturer states this anomaly causes increased PnP motion errors which could lead to delays in reporting patient sample results if unnoticed. The FDA classified the action as Class II.
Distribution was worldwide, including nationwide in the United States.
Laboratories should identify affected systems using the part number, UDI-DI and serial number above and follow the instructions issued by Beckman Coulter.
The recalled product
- Product
- DxI 800 Access Immunoassay Analyzer W/Dual Gantry, Part Number A71457
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 15099590369231
- Serial Numbers: 608109
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Beckman Coulter, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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