Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Access Immunoassay Systems

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Access Immunoassay Systemssee related information
Date Initiated by FirmSeptember 11, 2008
Date PostedApril 06, 2012
Recall Status1 Terminated 3 on June 26, 2012
Recall NumberZ-1373-2012
Recall Event ID 61118
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductAccess Immunoassay Systems Assay Protocol File (APF) Software versions for Access 2. Part Number: A15518, Access 2 APF Wash Buffer REF 81907, Part Number: A45142, Access 2 APF Wash Buffer II REF A16792. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentration found in human body fluids.
Code Information Part Number: A19889, Access APF Wash Buffer REF 81907  Lot Number: 714944, 717432, 720808, 821426, 823659.  Part Number: A45144, Access APF Wash Buffer REF A16792  Lot Number: 714939, 717433, 720811, 821429, 823661.
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information ContactB. Melina Cimler, Ph.D
714-993-8916
Manufacturer Reason
for Recall		The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total BhCG assay.
FDA Determined
Cause 2		Software design
ActionBeckman Coulter sent a "PRODUCT CORRECTIVE ACTION" letter dated September 24, 2008 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers were instructed to complete and return the enclosed response form. Customers with questions regarding this notification were instructed to contact Technical Support at (800) 854-3633 or their local Beckman Coulter representative.
Quantity in Commerce2948 units total (2762 units in the US)
DistributionWorldwide Distribution-USA (nationwide) and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-