Recalls / —

—#121917

Product

Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay

FDA product code

DLZ — Enzyme Immunoassay, Phenobarbital

Device class

Class 2

Medical specialty

Clinical Toxicology

510(k) numbers

K011528, K913190

Affected lot / code info

Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380.

Why it was recalled

Imprecision with certain lots

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Siemens sent an Urgent Medical Device Recall letter dated August 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product. Siemens will replace unused affected product at no charge. For replacements customers were instructed to incude this information on the Effectiveness Check form included with the letter. The Effectiveness Check form must be returned even if no replacement reagents are needed. The recall letter was to be retained with customers laboratory records and forwarded to those who may have received this product. Customers with questions were instructed to contact Siemens Technical Solutions or their Siemens technical support representative. For questions regarding this recall call 800-441-9250.

Recalling firm

Firm

Siemens Healthcare Diagnostics, Inc.

Address

500 Gbc Dr PO BOX 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

Distribution pattern

Worldwide Distribution - USA (nationwide) and Mexico.

Timeline

Recall initiated

2013-08-30

Posted by FDA

2013-11-07

Terminated

2014-08-27

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #121917. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.