CLASS II Device recall · Reported 3 Aug 2016 · FDA Enforcement Report
Syva¿ EMIT¿ 2000 Theophylline recalled
Siemens Healthcare Diagnostics is recalling Syva¿ EMIT¿ 2000 Theophylline, distributed in 24 states. The recall was initiated on 17 Jun 2016 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-2298-2016
- FDA event ID
- 74524
- Recalling firm
- Siemens Healthcare Diagnostics, Newark, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2016
- FDA classified
- 28 Jul 2016
- Reported
- 3 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Jun 2016 | Recall initiated by company | |
| 28 Jul 2016 | Classified by FDA | +41 days |
| 3 Aug 2016 | 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
Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples.
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
Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of theophylline in human serum or plasma.
Where it was distributed
Distributed to: CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA
CaliforniaConnecticutDelawareFloridaGeorgiaIowaIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMissouriNorth CarolinaNew JerseyNew MexicoNew YorkOhioOklahoma
Questions about this recall
Why was it recalled?
Siemens Healthcare Diagnostics has confirmed the Syva¿ EMIT¿ 2000 Theophylline reagent lot G3, when run on a Beckman AU Clinical Chemistry System, and the ADVIA¿ Chemistry Theophylline_2 (THEO_2) reagent lot 334018, may exhibit increased imprecision for commercially available Bio-Rad Liquichek TDM Quality Control Levels and patient samples.
Which lots are affected?
Syva¿ EMIT¿ 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 Syva¿ EMIT¿ 2000 Theophylline - kit lot G3
Where was it sold?
Distributed to: CA, CT, DE, FL, GA, IA, IN, KS, KY, LA, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, PA, TN, VA, WA
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.
Other products in this recall event
1 other product · FDA event 74524This product is part of a recall event; the main page for the event is Advia¿ Chemistry (Syva Onboard) Theophylline_2 recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Advia¿ Chemistry (Syva Onboard) Theophylline_2 recalled | Siemens Healthcare Diagnostics | Other | 24 states |
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