| | Class 3 Recall
Siemens Emit(R) tox(TM) Serum Calibrators |  |
| Date Posted |
January 10, 2013 |
| Recall Number |
Z-0665-2013 |
| Product |
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. |
| Code Information |
Lot D1
|
Recalling Firm/
Manufacturer |
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark, Delaware 19714-6101 |
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.
|
| Action |
Siemens sent a Customer Notification letter dated December 2012 to all affected customers of Emit(R) tox(TM) Serum Calibrators lot D1, informing them that Siemens Healthcare Diagnostics, Inc. has confirmed that the expiration of 2014-12-31 is incorrect. Siemens requested customers to discontinue use and discard any remaining inventory of the D1 lots. Customers were instructed to complete the Effectiveness Check form included with the letter even if no replacement reagents were needed and fax to 302-631-8467. Siemens would replace any unused kits of the affected lots at no charge.
Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local Siemens technical support representative.
For questions regarding this recall call 302-631-6311. |
| Quantity in Commerce |
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. |
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