Z-2208-2010

Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for monitoring system...

Name: Z-2208-2010 Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for monitoring system...
Creator: Beckman Coulter Inc.
Published: 2010-04-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-04-21 / Terminated / root cause: sterility

FDA source

Beckman Coulter Inc. began a recall of Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the... on 2010-04-21. The reason FDA records is "The recall was initiated after Beckman Coulter confirmed an issue with the Access AFP QC kits (REF 33219) which contain three levels of control material identified as QC1, QC2, and QC3, Beckman Coulter has confirmed...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2208-2010
Status: Terminated
Initiated: 2010-04-21
Posted: 2010-08-11
Terminated: 2012-05-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for monitoring system performance of immunoenzymatic procedures for the quantitative measurement of alpha-fetoprotein (AFP) using the Access Immunoassay Systems.
Product code: JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Reason for recall: The recall was initiated after Beckman Coulter confirmed an issue with the Access AFP QC kits (REF 33219) which contain three levels of control material identified as QC1, QC2, and QC3, Beckman Coulter has confirmed that vials of QC1 in the kit lots identified above contain microbial contamination. Customers may see that the results from a contaminated vial of QC1 are within the established refere
Root cause tag: sterility
FDA root cause: Other
Action: A Product Corrective Action (PCA) letter was sent on the week of April 19, 2010 to all customers who purchased the Access Immunoassay Systems AFP QC material, lot numbers referenced above. The letter provided the customers with an explanation of the problem identified and instructed the customers to (1) Please discard all remaining inventory of the three Access AFP QC kit lots identified above, including all vials of QC1, QC2, and QC3. (2) Please review your ac and patient results obtained while using the affected control lots. Interpret Access AFP test results in light of the clinical presentation of the patient, including: symptoms, clinical history, data from other tests and other appropriate information. (3) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. (4) Complete and return the enclosed response form within 10 days so we can be assured that you have received this important notification. For customers that need assistance or have any questions regarding this notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada.
Quantity in commerce: 166
Distribution: Nationwide and Canada
Product codes and lots: Lot Numbers: 911158, 911581, and 917631

Product code JJX

K981864Class IAccess Afp Qc on the Access Immunoassay Analyzer, Model Number 33219Beckman Coulter, Inc. / cleared 1998-06-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)