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U.S. Department of Health and Human Services

Class 2 Device Recall UniCel Dxl 800 Access lmmunoassay System

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 Class 2 Recall
UniCel Dxl 800 Access lmmunoassay System
see related information
Date Posted August 20, 2008
Recall Status1 Open
Recall Number Z-1184-2008
Recall Event ID 46336
Premarket Notification
510(K) Number
K023764 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Beckman Coulter UniCel Dxl 800 Access Immunoassay System; Part Number: 973100 With: UniCel Dxl 800 Modification (MOD ID 10027) and/or UniCel Dxl 800 Modification (MOD ID 6733), for in vitro diagnostic use.
Code Information Part Number 973100; Serial Numbers: 600469, 601097, 601098, 601144, 601182, 601160, 601188, 601071, 601117, 601114, 601137, 601059, 601039, 601099, 601088, 601176, 601184, 601178, 601025, 601186, 601110, 601063, 601002, 601029, 601133, 601106, 601215, 601159, 601077, 601202, 601206, 601079, 601051, 601179, 601130, 601058, 601031, 601212, 601173, 601028, 601078, 601094, 601210, 601189, 601228, 601043, 601092, 601171, 601026, 601122, 601208, 601103, 601089, 601108, 601183, 600933 600971, 600919, 600910, 600904, 600935, 601005, 600977, 600936, 600993, 600965, 601011, 600957, 600918, 601015, 600992, 600905, 600914, 600947, 601016, 601013, 600981, 600903, 600949, 601012, 600983, 600970, 600912, 601004, 600915, 600907, 600987, 600939, 600996, 601007, 600899, 601006, 600938, 600952, 600988, 601020, 600928, 600937, 600972, 955056, 965059, 954609, 949471, 954490, 501442, and 499300.
Recalling Firm/
Manufacturer
Beckman Coulter Inc
200 S Kraemer Blvd
Brea, California 92822-6208
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Nora Zerounian
714-961-3634
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
DESIGN: Device Design
Action 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.
Quantity in Commerce 111 units in the US; 9 units in Canada
Distribution Nationwide and Canada
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BECKMAN COULTER, INC.
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