Food, drugs, devices › Siemens Healthcare Diagnostics, Inc.
Device recall: Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immuno
FDA enforcement event 63892 is a device recall by Siemens Healthcare Diagnostics, Inc. of Newark, DE, initiated 10 Dec 2012 and classified Class II, with 1 product record.
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. 88% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 27 Aug 2014. 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., Newark, DE.
Reason for recall
"Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of"
Distribution
"Distributed in the states of CA, FL, IL, KS, MA, MI, MN, MS, NM, NY, NC, OH, OR, PA, TN, TX, UT, and WA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0664-2013 | Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homogeneous enzyme immunoassay intended for use in the quantitative analysis of Phenobarbital in human serum or plasma. | 1979 cartons | Class II | Terminated | 16 Jan 2013 |
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: "Firm has confirmed higher imprecision with the recalled lots on Beckman Coulter AU(R) Systems and the Syva(R) Emit(R) 2000 Phenobarbital (4D019UL) lots E1, E2, and E3 as an application if the AU(R) System is used, the issue may be experienced. Firm has found that within-run imprecision of the recalled lots frequency of outliers that differ from the expected value by 20%. This is an expansion of"
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: "Distributed in the states of CA, FL, IL, KS, MA, MI, MN, MS, NM, NY, NC, OH, OR, PA, TN, TX, UT, and WA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 27 Aug 2014. "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.