Z-1946-2018 Class II Terminated
FDA device recall Z-1946-2018 was initiated by Siemens Healthcare Diagnostics, Inc. on November 27, 2017 and is designated Class II. 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. The recall status is terminated (terminated April 19, 2019). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- June 6, 2018
- Initiation Date
- November 27, 2017
- Termination Date
- April 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Catalog # 4P019UL /SMN#10445324 kit lot J1 (UDI# 00842768001024J120190414)