Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1946-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 27, 2017

Date Posted: June 6, 2018

Recall Number: Z-1946-2018

Event ID: 79413

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.

Status: Terminated

Product Quantity: N/A

Code Information:

Catalog # 4P019UL /SMN#10445324 kit lot J1 (UDI# 00842768001024J120190414)

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated