Recall Z-1946-2018— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1946-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-27

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2017-11-27, terminated 2019-04-19. It names one FDA 510(k) clearance: K913123. 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.. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-27
Terminated: 2019-04-19
Firm location: Newark, DE, United States

510(k) clearances named in this recall

1 on FDA's record

K913123 — EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORSSyva Co.·cleared 1991-09-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.