Recall Z-0181-2014— Siemens Healthcare Diagnostics, Inc.
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2013-08-30, terminated 2014-08-27. It names 2 FDA 510(k) clearances: K011528, K913190. Product: Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay. Reason: Imprecision with certain lots.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-30
- Terminated
- 2014-08-27
- Firm location
- Newark, DE, United States
510(k) clearances named in this recall
2 on FDA's record- K011528 — EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229
- K913190 — EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Reason for recall
Imprecision with certain lots
Data sourced from openFDA. This site is unofficial and independent of the FDA.