Recall Z-1195-2012 ยท CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Beckman Coulter Inc.
ACCESS Ostase Part Number: 37300 Used for the quantitative measurement of bone alkaline phosphatase (BAP).
| Date | Mar 9, 2012 (initiated Jun 22, 2011) |
| Status | Terminated |
| 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 p |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994278 | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY Beckman Coulter, Inc., Mar 28, 2000 |