FDA Medical Device Recalls (openFDA)
Siemens Healthcare Diagnostics, Inc.: Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
- Recall number
- Z-0181-2014
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Product
- Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
- Status
- Terminated
- Initiated
- 2013-08-30
- Posted
- 2013-11-07
- Terminated
- 2014-08-27
- Reason
- Imprecision with certain lots
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 4963
- Distribution
- Worldwide Distribution - USA (nationwide) and Mexico.
- Lot, serial or model codes
- Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380.
- 510(k) numbers
- ["K011528","K913190"]
- PMA numbers
- not on file
- Product code
- DLZ
- Firm FEI
- 2517506
- Firm city
- Newark
- Firm state
- DE
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28