Z-2298-2016Class II

Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended...

Name: Z-2298-2016 Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended...
Creator: Siemens Healthcare Diagnostics, Inc.
Published: 2016-06-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-06-17 / Terminated / root cause: manufacturing process

FDA source

Siemens Healthcare Diagnostics, Inc. began a recall of Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline... on 2016-06-17. FDA classified it as Class II and gives the reason as "Siemens Healthcare Diagnostics has confirmed the Syva EMIT 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may...". 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-2298-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-17
Posted: 2016-07-28
Terminated: 2017-03-15
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 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: Siemens Healthcare Diagnostics has confirmed the Syva EMIT 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Siemens Healthcare Diagnostics mailed a letter to customers on June 17, 2016, asking that they discontinue use of and discard the affected kit lots identified in the recall notification letter. Customers were also asked to complete and return the Field Correction Effectiveness Check/Product Replacement Form that was mailed with the Recall Notification Letter.
Quantity in commerce: 1,004 units
Distribution: Distributed to: CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA
Product codes and lots: Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 Syva¿ EMIT¿ 2000 Theophylline - kit lot G3

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2298-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2298-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-28
Z-2299-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-03	2016-07-28

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)