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 | The solid phase reagent in some of the ADVIA Centaur® TnI -Ultra ReadyPacks®, lot 084, is darker in appearance, creating a potential for incorrect control and patient results. |
| Product | ADVIA Centaur® Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790 |
| Quantity | 34,283 kits |
| Distribution | Worldwide Distribution-USA (nationwide) including PR and the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY, and the countries of Canada, Mexico, Argentina, Austria, Australia. Bahrain, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Costa Rica, Croat… |
| Initiated | 2014-05-30 |
| Classified | 2014-07-02 |
| Terminated | 2016-02-26 |
| Recall number | Z-1991-2014 |
| 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-1991-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68520/
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