Beckman Coulter Inc. Access Immunoassay Systems Total hCG. The Access Total hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total hCG levels in human serum and plasma using the Access Immunoassay Systems. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Access Immunoassay Systems Total hCG. The Access Total hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total hCG levels in human serum and plasma using the Access Immunoassay Systems.
Brand
Beckman Coulter Inc.
Lot Codes / Batch Numbers
Lot Numbers 824542 and 825652.
Products Sold
Lot Numbers 824542 and 825652.
Beckman Coulter Inc. is recalling Access Immunoassay Systems Total hCG. The Access Total hCG assay is a paramagnetic particle, chemil due to The recall was initiated because Beckman Coulter has confirmed that certain Access Total hCG reagent packs show decreased stability from the date of m. 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 Coulter has confirmed that certain Access Total hCG reagent packs show decreased stability from the date of manufacture, which may lead to increased imprecision.
Recommended Action
Per FDA guidance
The recall communication was initiated on March 18, 2009 with Beckman Coulter forwarding an Urgent: Product Corrective Action (PCA) letter dated March 13, 2009 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems total hCG. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discontinue use of the reagent lot numbers 824542 and 825652, and discard any unused reagent packs. Customers were asked to review their historical records for low level quality control to ensure that the assay performance for the referenced lot numbers has been within their laboratory specifications. They were also asked to share the information with their laboratory staff and retain the letter for their Quality System documentation, and then complete and return the enclosed response form within 10 days so that they may be assured that consignees received the notification. Finally they were told to contact Customer Technical Support Center at 1-800-854-3633 in the US and Canada, or their local Beckman Coulter Representative with any questions.
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 noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026