Z-1195-2012

ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline phosphatase (BAP)

Name: Z-1195-2012 ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline phosphatase (BAP)
Creator: Beckman Coulter Inc.
Published: 2011-06-22
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-06-22 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline phosphatase (BAP) on 2011-06-22. The reason FDA records is "The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results". 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-1195-2012
Status: Terminated
Initiated: 2011-06-22
Posted: 2012-03-09
Terminated: 2012-03-09
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline phosphatase (BAP).
Product code: CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Reason for recall: The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: A recall communication was initiated on 6/15/2011 with Beckman forwarding an "Urgent Product Correction" (PCA) letter to all their customers who purchased the Access Immunoassay Systems Ostase Reagent Kits. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discontinue use of the Access Ostase reagent lot identified on the PCA letter and discard all remaining inventory. As stated in the Instructions for Use for Access Ostase, results should be interpreted in light of the total clinical presentation of the patient. All results generated with reagent lot number 021281 where patient results are higher than expected should be evaluated. The affected lot has been removed from Beckman's inventory, and alternate lots will be provided for all current and future replenishment orders or requests. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions can contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support or call(800) 854-3633 in the US and Canada.
Quantity in commerce: 318 units total (44 units in US)
Distribution: Worldwide Distribution -- US, including states of FL, IN, VA, CA, and KY and countries of China, Japan, and Panama.
Product codes and lots: Lot Number: 021281

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)