Recall Z-0025-2025

Reason for recall

When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.

FDA-determined cause: Software design

Action taken

The recalling firm issued letters dated 4/12/2024 on 4/18/2024 via first class mail. The letter described the issue, the impact, and actions to be taken, which included: (a) Verify the calibrator material expiration date before ordering a calibration on the analyzer; (b) Cancel calibration orders after the calibrator lot material expires. Instructions for canceling a calibration order are provided in the device help system or in the Calibration section of the IFU; (c) Repeat any test results generated from a calibration curve that used expired calibrator lot material. The resolution provided was that the firm is investigating the root cause of the issue and will implement the correction with a future software release. A service representative will contact the consignee to schedule the software upgrade when it is available. The letter is to be shared with laboratory staff and retained as part of the laboratory Quality System documentation. If the device has been forwarded to another laboratory, the consignee is to provide a copy of the letter to that laboratory. A Response Form was enclosed for completion and return within 10 days to assure the information has been received.