Recall Z-2605-2011 ยท JIS Calibrator, Primary
Beckman Coulter Inc.
Access Immunoassay Systems Ostase Calibrators, Part Number: 37305 The Access Ostase Calibrators are used 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.
| Date | Jun 21, 2011 (initiated May 10, 2011) |
| Status | Terminated |
| Reason | The recall was initiated because Beckman Coulter has confirmed that Access Ostase Calibrator and QC vials from the affected lots have shown an increased rate of fracturing and may leak the contents in the box during shipment to customers. Operator injury may occur due to contact with broken glass, exposure to infectious agents, and/or exposure by skin contact to agents that may cause sensitizatio |
| Root cause | Package design/selection |
| Action | Beckman Coulter sent an PRODUCT CORRECTIVE ACTION (PCA) letter on May 10, 2011 to all affected customers who purchased Access Ostase Calibrators and Access Ostase QC. The letter identified the customers with an explanation of the problem and the potential impact should the problem occur and the action needed to be taken. Customer were instructed to: (1) Inspect all Access Ostase Calibrator and QC vials and packaging for signs of failure prior to use, including: -Cracking, particularly along the bottom of the vial, -Absence of reagent and/or leaking of contents into the box (2) Human sourc |
| Quantity | 189 kits |
| Distribution | Nationwide in US and worldwide to: Algeria, Argentina, Australia, Austria, Belgium, Canada, China, Colombia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Lebanon, Liechtenstein, Mexico, Morocco, New Zealand, Panama, Reunion, Romania, Russian Fed |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K994278 | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY Beckman Coulter, Inc., Mar 28, 2000 |