Beckman Coulter Inc. Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access. Part Number: A19889, Access APF Wash Buffer REF 81907, Part Number: A45144, Access 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access. Part Number: A19889, Access APF Wash Buffer REF 81907, Part Number: A45144, Access 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.
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Beckman Coulter Inc. is recalling Access Immunoassay Systems Assay Protocol File (APF) Software versions for Access. Part Number: A19 due to The recall was initiated because Beckman confirmed a customer report that a timing conflict can occur while aspirating samples for the Access Total Bh. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Beckman 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026