CLASS II Device recall · Reported 16 Sep 2015 · FDA Enforcement Report
Advia Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent recalled
Siemens Healthcare Diagnostics is recalling Advia Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent, distributed nationwide in the US. The recall was initiated on 27 Jul 2015 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-2739-2015
- FDA event ID
- 71843
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jul 2015
- FDA classified
- 4 Sep 2015
- Reported
- 16 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 27 Jul 2015 | Recall initiated by company | |
| 4 Sep 2015 | Classified by FDA | +39 days |
| 16 Sep 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
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
ADVIA Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Blood Cell hemolysate for use with the ADVIA Centaur systems folate assay.
Where it was distributed
Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.
Nationwide CaliforniaConnecticutFloridaGeorgiaIowaIllinoisKansasKentuckyMassachusettsMarylandMichiganMissouriNew JerseyNew MexicoNevadaNew YorkPennsylvaniaRhode IslandSouth CarolinaTennessee
Questions about this recall
Is Advia Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent recalled?
Yes. Siemens Healthcare Diagnostics recalled Advia Centaur¿ Folate Ascorbic Acid/Ascorbic Acid Diluent on 27 Jul 2015. The recall is Class II and its status is Terminated. Recall number Z-2739-2015.
Why was it recalled?
Low red blood cell control recoveries and low results for red blood cell patient samples when using the ADVIA Centaur Systems Folate assay.
Which lots are affected?
Lot Number/Expiration: 54942 2015-11-17; 56230 2015-11-17; 70673 2015-11-17
Where was it sold?
Worldwide Distribution-US (nationwide) including the states of CA CT DE FL GA IA IL IN KS KY MA MD MI MO NJ NM NV NY OH PA RI SC TN TX VA WA WI and OUS: Belgium Estonia Finland France Germany Great Britain Ireland Italy Pakistan Spain Sweden Switzerland Turkey.
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 21 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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