UniCel Dxl 800 Access lmmunoassay System 의 리콜

Recall

46336

Class 2

Z-1184-2008

2007-10-08

2008-08-20

Terminated

United States

2012-01-11

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67204

Incorrect results: there is an increased variance in assay performance when the unicel dxl 800 modification (mod id 10027) and/or unicel dxl 800 modification (mod id 6733) have been implemented and there are room fluctuations after assay calibration between the extremes of the 18¿c and 32¿c operating range.

Beckman Coulter mailed a Product Corrective Action (PCA) letter the week of October 8, 2007 to the customers who have the affected UniCel Dxl 800 Access lmmunoassay systems advising that there is an increased variance in assay performance when the UniCel Dxl 800 Modification (MOD ID 10027) and/or UniCel Dxl 800 Modification (MOD ID 6733) have been implemented and there are room fluctuations after assay calibration between the extremes of the 18¿C and 32¿C operating range. The letter further advises that Beckman Coulter will contact the customer to arrange a date to remove the modificatlons but until the modification is completed, the system should be operated in a room temperature of 20¿C to 30¿C. This can be acomplished by monitoring and recording room tamperature in the area of the instrument. Customers are also asked to review historical quality control records to ensure assay performance is within their laboratory specification and that patient results should be reviewed in context of other diagnostics tests and the clinical presentations of the patient. A response form is included.