IMMULITE 2000 — Class II medical device recall Z-1316-2014
Terminated recall by Siemens Medical Solutions Diagnostics, reported 2014-04-09, distributed nationwide. There is a potential for incorrect results to be reported from processing of a sample tube.
| Recall number | Z-1316-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions Diagnostics, Flanders, NJ, United States |
| Recall initiated | 2014-02-03 |
| Classified | 2014-04-02 |
| Reported by FDA | 2014-04-09 |
| Terminated | 2016-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 1,006 units |
Product
IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing. The VersaCell system is a robotic sample-moving device that supports an interface to a number of laboratory analysis systems, such as the IMMULITE 2000
Reason for recall
There is a potential for incorrect results to be reported from processing of a sample tube.
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-1316-2014. 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.