Z-1238-2012

Access Ostase Calibrators, Part Number: 37305, Subsequent

Name: Z-1238-2012 Access Ostase Calibrators, Part Number: 37305, 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 Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access Ostase Calibrators are intended to calibrate the Access Ostase assay... 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-1238-2012
Status: Terminated
Initiated: 2011-11-10
Posted: 2012-03-21
Terminated: 2012-06-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Ostase Calibrators, Part Number: 37305, Subsequent Product Code: JIS. The Access Ostase Calibrators are intended to calibrate the Access Ostase assay for the quantitative determination of bone alkaline phosphatase (BAP) levels in human serum and plasma using the Access Immunoassay Systems.
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: 2,228 units total (440 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: 013489 11/30/2010 111530 09/30/2011 013490 01/31/2011 113463 10/31/2011 015210 02/28/2011 114259 10/31/2011 018854 03/31/2011 114260 11/30/2011 020419 05/31/2011 115484 12/31/2011 022834 06/30/2011 116658 01/31/2012 109632 07/31/2011

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)