Z-0047-2013Class II

Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate...

Name: Z-0047-2013 Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate...
Creator: Beckman Coulter Inc.
Published: 2012-07-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-07-24 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access... on 2012-07-24. FDA classified it as Class II and gives the reason as "Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0047-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-24
Posted: 2012-10-10
Terminated: 2013-10-17
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems
Product code: JIT Calibrator, Secondary
Reason for recall: Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated July 24, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Customers were instructed to complete and return the enclosed Response Forms within 10 days. Customers with questions were instructed to call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter representative.
Quantity in commerce: 5,266 units total (3,214 units in US)
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Australia, Bangladesh, Belgium, Botswana, Brazil, Canada, China, Colombia, Czech Republic, Croatia, Ecuador, Ethiopia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Oman, Pakistan, Panama, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Sweden, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zimbabwe.
Product codes and lots: Lot# 122651, 123635, 219962

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0047-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0046-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10
Z-0047-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-10

Product code JIT

K111952Class IIAccess Folate Calibrators on the Access Immunoassay Systems Model A98033Beckman Coulter, Inc. / cleared 2011-08-19

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)