FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: 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.
- Recall number
- Z-1238-2012
- Recalling firm
- Beckman Coulter 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.
- Status
- Terminated
- Initiated
- 2011-11-10
- Posted
- 2012-03-21
- Terminated
- 2012-06-26
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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
- 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