Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Ca...
FDA Recall #Z-0665-2013 — Class III — December 6, 2012
Product Description
Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibrators are intended for use with the Emit(R) tox(TM) Serum Barbiturate and Benzodiazepine Assays as a reference for the semi-quantitative analis of barbiturates and benzodiazepines in human serum.
Reason for Recall
Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 2014-12-31.
Recalling Firm
Siemens Healthcare Diagnostics, Inc. — Newark, DE
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
1,998 cartons
Distribution
Nationwide Distribution to the following states: AL, AR, CA, CO, FL, GA, IL, IN, KY, MA, MD, MI, MO, NC, NY, OH, PA, TN, TX and WI.
Code Information
Lot D1
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated