Z-0181-2014Class II

Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay

Name: Z-0181-2014 Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2013-08-30
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-08-30 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay on 2013-08-30. FDA classified it as Class II and gives the reason as "Imprecision with certain lots". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0181-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-30
Posted: 2013-11-07
Terminated: 2014-08-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Product code: DLZ Enzyme Immunoassay, Phenobarbital
Reason for recall: Imprecision with certain lots
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent an Urgent Medical Device Recall letter dated August 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product. Siemens will replace unused affected product at no charge. For replacements customers were instructed to incude this information on the Effectiveness Check form included with the letter. The Effectiveness Check form must be returned even if no replacement reagents are needed. The recall letter was to be retained with customers laboratory records and forwarded to those who may have received this product. Customers with questions were instructed to contact Siemens Technical Solutions or their Siemens technical support representative. For questions regarding this recall call 800-441-9250.
Quantity in commerce: 4963
Distribution: Worldwide Distribution - USA (nationwide) and Mexico.
Product codes and lots: Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0181-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0181-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-07

Product code DLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)