Recall Z-0181-2014
Siemens Healthcare Diagnostics, Inc. · initiated August 30, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Codes / lots: Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380.
Reason for recall
Imprecision with certain lots
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0181-2014
- Initiated
- August 30, 2013
- Posted by FDA
- November 7, 2013
- Terminated
- August 27, 2014
- Product code
- DLZ – Enzyme Immunoassay, Phenobarbital
- Quantity
- 4963
- Distribution
- Worldwide Distribution - USA (nationwide) and Mexico.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE