Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
FDA device recall Z-0181-2014 · posted 2013-11-07 · Terminated
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Imprecision with certain lots
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DLZ
- Quantity affected
- 4963
- Distribution
- Worldwide Distribution - USA (nationwide) and Mexico.
- Date initiated
- 2013-08-30
- Date posted
- 2013-11-07
- Date terminated
- 2014-08-27
- Location
- Newark, DE
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 (K011528) | Syva Co. | 2001-06-06 |
| EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS (K913190) | Syva Co. | 1991-08-26 |