FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline phosphatase (BAP).
- Recall number
- Z-1195-2012
- Recalling firm
- Beckman Coulter Inc.
- Product
- ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline phosphatase (BAP).
- Status
- Terminated
- Initiated
- 2011-06-22
- Posted
- 2012-03-09
- Terminated
- 2012-03-09
- Reason
- The Access Ostase reagent lot 021281 shows instability resulting in falsely high patient results.
- 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
- 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.
- Lot, serial or model codes
- Lot Number: 021281
- 510(k) numbers
- ["K994278"]
- PMA numbers
- not on file
- Product code
- CIN
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28