Recall Z-2298-2016 ยท KLS Enzyme Immunoassay, Theophylline
Siemens Healthcare Diagnostics, Inc.
Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
| Date | Jul 28, 2016 (initiated Jun 17, 2016) |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics has confirmed the Syva EMIT 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples. |
| Root cause | Process control |
| Action | Siemens Healthcare Diagnostics mailed a letter to customers on June 17, 2016, asking that they discontinue use of and discard the affected kit lots identified in the recall notification letter. Customers were also asked to complete and return the Field Correction Effectiveness Check/Product Replacement Form that was mailed with the Recall Notification Letter. |
| Quantity | 1,004 units |
| Distribution | Distributed to: CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA |
| 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 |