Recall Z-1946-2018 ยท KLS Enzyme Immunoassay, Theophylline
Siemens Healthcare Diagnostics, Inc.
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.
| Date | Nov 27, 2017 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913123 | EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS Syva Co., Sep 19, 1991 |