CLASS II Device recall · Reported 13 Nov 2013 · FDA Enforcement Report
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay recalled
Siemens Healthcare Diagnostics is recalling Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay, distributed nationwide in the US. The recall was initiated on 30 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0181-2014
- FDA event ID
- 66267
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Aug 2013
- FDA classified
- 7 Nov 2013
- Reported
- 13 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 30 Aug 2013 | Recall initiated by company | |
| 7 Nov 2013 | Classified by FDA | +69 days |
| 13 Nov 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Imprecision with certain lots
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
Where it was distributed
Worldwide Distribution - USA (nationwide) and Mexico.
Questions about this recall
Why was it recalled?
Imprecision with certain lots
Which lots are affected?
Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380.
Where was it sold?
Worldwide Distribution - USA (nationwide) and Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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