RecallRadar

FDA Device recall Z-0181-2014

Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay

On 2013-11-13 the FDA classified a Class II recall of Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay by Siemens Healthcare Diagnostics, citing imprecision with certain lots.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0181-2014
ClassificationClass II
Statusterminated
Initiated2013-08-30
Published2013-11-13
Last updated2026-09-13 11:53 UTC
CompanySiemens Healthcare Diagnostics
DistributionUS

Product

Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay

Reason

Imprecision with certain lots

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0181-2014%22

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