CLASS II Device recall · Reported 2 Jul 2014 · FDA Enforcement Report
Siemens Healthcare Advia Acid/Base Reagent recalled
Siemens Healthcare Diagnostics is recalling Siemens Healthcare Advia Acid/Base Reagent 1 and 2 Kit containing Advia Centaur Acid, distributed nationwide in the US. The recall was initiated on 2 Jun 2014 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-1927-2014
- FDA event ID
- 68537
- Recalling firm
- Siemens Healthcare Diagnostics, East Walpole, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jun 2014
- FDA classified
- 26 Jun 2014
- Reported
- 2 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 2 Jun 2014 | Recall initiated by company | |
| 26 Jun 2014 | Classified by FDA | +24 days |
| 2 Jul 2014 | 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
Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles, lot number: 454778 Kit Catalog Number: 112219 SMN: 10310026 Intended Use: In vitro diagnostic use. Acid Regent is a component of the ADVIA Centaur and ADVIA Centaur XP instruments
Where it was distributed
Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.
Questions about this recall
Why was it recalled?
Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles
Which lots are affected?
Kit Lot Number: 454779 Exp. Date: 28 February, 2015
Where was it sold?
Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.
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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