FDA Device recall Z-0407-2017
Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Osta…
- FDA Device
- Class II
- terminated
- Published 2016-11-23
On 2016-11-23 the FDA classified a Class II recall of Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: The Access Ostase Calibrators are intended to calibrate the Access Osta… by Beckman Coulter, citing beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0407-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-24 |
| Published | 2016-11-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Access Ostase Calibrators, Catalog No. 37305, B83876 Product Usage: 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.
Reason
Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.
Identifiers
| code_info | 623207 626000 628294 628296 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0407-2017%22
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