Food, drugs, devices › Siemens Healthcare Diagnostics, Inc
Device recall: ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN
Siemens Healthcare Diagnostics, Inc (East Walpole, MA) initiated this device recall on 30 May 2014; FDA lists 1 product record under event 68520, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 26 Feb 2016. Initiation: voluntary: firm initiated. Siemens Healthcare Diagnostics, Inc has 333 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Siemens Healthcare Diagnostics, Inc, East Walpole, MA.
Reason for recall
"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."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1991-2014 | ADVIA Centaur¿ Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 02790309 (500 tests), SMN 10317790 | 34,283 kits | Class II | Terminated | 9 Jul 2014 |
Context
Other enforcement events for Siemens Healthcare Diagnostics, Inc
All 333 events for Siemens Healthcare Diagnostics, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 26 Feb 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.