Siemens Dimension Vista — Class III medical device recall Z-0988-2013
Terminated recall by Siemens Healthcare Diagnostics, Inc., reported 2013-04-03, distributed nationwide. Correlation slope bias and accuracy shift
| Recall number | Z-0988-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Inc., Tarrytown, NY, United States |
| Recall initiated | 2012-10-10 |
| Classified | 2013-03-25 |
| Reported by FDA | 2013-04-03 |
| Terminated | 2014-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 1,985 cartons |
| Lot numbers | 2AD052 |
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 for recall
Correlation slope bias and accuracy shift
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0988-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.