Class II — Siemens Healthcare Diagnostics, Inc.
| Recalling firm | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|---|---|
| Registered facility | View this company's 12 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results. |
| Product | Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) |
| Quantity | 276,511 |
| Distribution | Distributed in all 50 U.S. states, the District of Columbia, Guam, and Puerto Rico. Distributed in 108 foreign countries: Afghanistan Bolivia Albania® Algeria® Angola ARGENTINA Armenia AUSTRALIA Austria® Azerbaijan Bahamas Bahrain® Bangladesh® Belarus® Belgium® BosniaHerzeg. Brazil Bulgaria® Cambodia Canada … |
| Initiated | 2017-06-29 |
| Classified | 2018-05-04 |
| Terminated | 2020-04-23 |
| Recall number | Z-1650-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Siemens Healthcare Diagnostics, Inc. (Z-1650-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79225/
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