| Class 3 Device Recall Siemens Emit(R) tox(TM) Serum Calibrators | |
Date Initiated by Firm | December 06, 2012 |
Date Posted | January 10, 2013 |
Recall Status1 |
Terminated 3 on December 24, 2013 |
Recall Number | Z-0665-2013 |
Recall Event ID |
63941 |
510(K)Number | K790735 |
Product Classification |
Calibrators, drug mixture - Product Code DKB
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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 Dr Ms 514 PO BOX 6101 Newark DE 19702-2466
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For Additional Information Contact | 800-441-9250 |
Manufacturer 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. |
FDA Determined Cause 2 | Error in labeling |
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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DKB
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