Z-0572-2013Class II

The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative...

Name: Z-0572-2013 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative...
Creator: Beckman Coulter Inc.
Published: 2012-11-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2012-11-05 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human... on 2012-11-05. FDA classified it as Class II and gives the reason as "Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to...". 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-0572-2013
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Posted: 2012-12-20
Terminated: 2014-05-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems. The Access hLH Calibrators are intended to calibrate the Access hLH assay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoassay Systems.
Product code: CEP Radioimmunoassay, Luteinizing Hormone
Reason for recall: Beckman Coulter Inc. (BEC) has demonstrated that real time stability testing of hLH Calibrator of certain lots have failed the 13-month and 14-month time points. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these lots did not meet BEC's procedural requirements for a 12-month shelf-lif
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beckman Coulter Inc. (BEC) sent an "URGENT FIELD SAFETY NOTICE" dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Per BEC's real time stability procedure, in order to verify expiration dating, one additional month is needed beyond the claimed expiration period. Therefore, these the affected lots did not meet BEC's procedural requirements for a 12-month shelf-life claim. Contact the firm at 952-448-4848 for assistance with this recall.
Quantity in commerce: 14409
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libyan Arab Jamahiriya, Macao, Malaysia, Mexico, Moldova Republic, Morocco, Myanmar, Namibia, Netherlands, Netherlands Antilles, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Yemen, Zambia, and Zimbabwe
Product codes and lots: Lots: 220438, 122157, 118299, 113689, 109784, 022519, 014099, 011895, 008546, 916872

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0572-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0572-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-26	2012-12-20

Product code CEP

K940549Class IAccess(r) Human Luteinzing Hormone AssayBio-Rad Laboratories, Inc. / cleared 1994-04-06

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)