FDA Device recall Z-0988-2013
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the A…
- FDA Device
- Class III
- terminated
- Published 2013-04-03
On 2013-04-03 the FDA classified a Class III recall of Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the A… by Siemens Healthcare Diagnostics, citing correlation slope bias and accuracy shift.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0988-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-10-10 |
| Published | 2013-04-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnostic product for the calibration of the Alkaline Phosphatase method on the Dimension Vista" System.
Reason
Correlation slope bias and accuracy shift
Identifiers
| code_info | Lot 2AD052 Catolog KC330 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0988-2013%22
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