Z-1946-2018Class II

Syva EMIT 2000 Theophylline

Name: Z-1946-2018 Syva EMIT 2000 Theophylline
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2017-11-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-11-27 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative... on 2017-11-27. FDA classified it as Class II and gives the reason as "Lot J1 of the Syva EMIT 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient samples". 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-1946-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-27
Posted: 2018-05-25
Terminated: 2019-04-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
Product code: KLS Enzyme Immunoassay, Theophylline
Reason for recall: Lot J1 of the Syva EMIT 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially available controls and for patient samples.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Siemens sent an Urgent Medical Device Recall letter dated November 27, 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use of affected product, review inventory to determine replacement needs, complete and return Field Correction Effectiveness Check list. For questions contact Siemens Customer Care Center or your local Siemens technical support representative.
Distribution: US Nationwide Distribution
Product codes and lots: Catalog # 4P019UL /SMN#10445324 kit lot J1 (UDI# 00842768001024J120190414)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1946-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1946-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25

Product code KLS

K913123Class IIEmit(r) 2000 Theophylline Assay/calibratorsSyva Co. / cleared 1991-09-19

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)