—#115082

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.

FDA product code: DKB — Calibrators, Drug Mixture
Device class: Class 2
Medical specialty: Clinical Toxicology
510(k) numbers: K790735
Affected lot / code info: Lot D1

Why it was recalled

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.

Root cause (FDA determination)

Error in labeling

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2012-12-06
Posted by FDA: 2013-01-10
Terminated: 2013-12-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #115082. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.