Recall Z-1240-2012 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Beckman Coulter Inc.
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.
| Date | Mar 21, 2012 (initiated Nov 10, 2011) |
| Status | Terminated |
| 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 | 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, Netherl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994278 | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY Beckman Coulter, Inc., Mar 28, 2000 |