Z-1240-2012

Access Ostase Reagent, Part Number: 37300, subsequent

Name: Z-1240-2012 Access Ostase Reagent, Part Number: 37300, subsequent
Creator: Beckman Coulter Inc.
Published: 2011-11-10
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-11-10 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase Assay is used for the quantitative measurement of bone alkaline... on 2011-11-10. The reason FDA records is "The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released...". 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-1240-2012
Status: Terminated
Initiated: 2011-11-10
Posted: 2012-03-21
Terminated: 2012-06-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Ostase Reagent, Part Number: 37300, subsequent product code: JIS. The Access Ostase Assay is used for the quantitative measurement of bone alkaline phosphatase (BAP), an indicator of osteoblastic activity, in human serum and plasma. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Pagets disease.
Product code: CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Reason for recall: The recall was initiated because Beckman confirmed that the Access Ostase Calibrator and QC lots do not meet expiration date claims. The Access Ostase Reagent Kit lots identified were quality control tested and released using Access Ostase Calibrator and QC lots that contain the implicated raw material.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Beckman Coulter sent an "URGENT PRODUCT CORRECTION" letter dated November 9, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use and discard all remaining inventory. In addition, a Response Form was enclosed for customers to complete and return. Contact Beckman's Customer Support Center at (800) 854-3633 for questions regarding this notice.
Quantity in commerce: 8228 units total (1193 units in US)
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, India,Ireland, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, Netherlands, New Zealand, Panama, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, and Venezuela.
Product codes and lots: Lot Numbers: Expiration dates: 011167 04/30/2011 017561 09/30/2011 014486 7/31/2011

Product code CIN

K994278Class IIAccess Ostase Immunoenzymetric AssayBeckman Coulter, Inc. / cleared 2000-03-28

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)