FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.
- Recall number
- Z-3023-2011
- Recalling firm
- Beckman Coulter Inc.
- Product
- Access Immunoassay Systems UNCONJUGATED ESTRIOL Part # 33570 The Access Unconjugated Estriol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of unconjugated estriol levels in human serum using the Access Immunoassay Systems.
- Status
- Terminated
- Initiated
- 2009-12-08
- Posted
- 2011-08-15
- Terminated
- 2012-04-16
- Reason
- The recall was initiated because Beckman Coulter has confirmed customer reports that a single lot of Access Unconjugated Estriol reagent (PIN 33570) may produce suppressed patient results and an increased incidence of IND (Indeterminate) flags. These issues have been associated with reagent lot 913348. This reagent met all testing specifications prior to release.
- Root cause
- Other
- Action
- Beckman Coulter sent a PRODUCT CORRECTIVE ACTION (PCA) letter dated December 8, 2009, to all affected customers. The letter was sent via US Postal Service for all US customers with attached PCA response form. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to discontinue use of Access Unconjugated Estriol reagent lot number 913348. " No further orders of Access Unconjugated Estriol reagent lot number 913348 will be shipped. " Abnormally low Access Unconjugated Estriol results from samples tested previously with the affected lot should be reviewed in the context of other diagnostic tests. " Access Unconjugated Estriol 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. Rerun any tests that produce a questionable result. In addition, customers were instructed to complete and return the enclosed PCA Response Form within 10 days. Customers with any technical questions regarding this Product Corrective Action were instructed to call Beckman Coulter Customer Service at (800) 854-3633 in the US and Canada. Outside of Canada and the US, customers were instructed to contact their local Beckman Coulter Representative.
- Quantity
- 2786 units total (2776 in the US)
- Distribution
- Worldwide Distribution -- USA (nationwide) including the states of CA, CT, MA, NC, NM and TX and the country of Canada.
- Lot, serial or model codes
- Lot # 913348
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CGI
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28