—#162253

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.

FDA product code: KLS — Enzyme Immunoassay, Theophylline
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K913123
Affected lot / code info: Catalog # 4P019UL /SMN#10445324 kit lot J1 (UDI# 00842768001024J120190414)

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2017-11-27
Terminated: 2019-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162253. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.