Device Recall Access AccuTnI Assay 의 리콜

Recall

55206

Class 2

Z-1995-2010

2010-03-11

2010-07-12

Terminated

United States

2012-05-04

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90300

The recall was initiated because as a follow up to pca # 12605 dated december 16, 2009, beckman coulter has confirmed additional reports that each of the following assays may produce lower than expected results when run in conjunction with access accutnl (ref a78803): (1) access testosterone (ref 33560); (2) access thyroid uptake (ref 33810); (3) access total t4 (ref 33800). this issue can occ.

The firm, Beckman Coulter, issued a "URGENT: PRODUCT CORRECTIVE ACTION" (PCA) letter with attached Customer Response form dated March 24, 2010 to all customers. The letter describes the issue, impact, action and resolution. In the PCA beckman Coulter recommends the following mitigation to reduce the risk of generating erroneous results: (1) Verify the APF software on the immunoassay system. If the updated APF software listed in the table above was already loaded , skip the remainder of this section and proceed to the Resolution section; (2) If the updated APF software has not yet been loaded, but is available, load the software appropriate for the system, skip the remainder of this section and proceed to the Resolution section; (3) If the updated APF software is not immediately available, please contact Technical Support at 1-800-854-3633 in the United States and Canada. Consignees outside the United States and Canada, contact their local Beckman Coulter Representative and follow the instructions below until the software has been loaded on their system. (a) Access and Access 2 users should batch process Access Testosterone, Thyroid Uptake, or Total T4 samples; (b) For UniCel DxI users, assign Access AccuTnI (REF A78803) to a different reagent pipettor(s) than Access Testosterone, Thyroid Uptake, or Total T4; (c) The Access Testosterone, Thyroid Uptake, or Total T4 results should be interpreted in light of the total clinical presentation of the patient, including: symptoms, clinical history, data from additional tests, and other appropriate information. Abnormally low Access Testosterone, Thyroid Uptake, or Total T4 results from samples tested in conjunction with Access AccuTnI (REF A78803) should be reviewed in the context of other diagnostic tests. Customers were instructed that after loading the updated APF software, the Access AccuTnI assay (REF A78803, test code TropI, test ID 275) must be recalibrated. Recalibrate of the Access Testosterone, T