Siemens Healthcare Recalls ADVIA Acid/Base Reagent Kits Due to Metal Contamination
Siemens Healthcare is recalling ADVIA Acid/Base Reagent 1 and 2 Kits because trace metal contamination caused the acid bottles to swell.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (swollen bottles due to contamination) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 3,839 kits of the ADVIA Acid/Base Reagent 1 and 2 Kit. The affected product includes ADVIA Centaur Acid Reagent bottles with lot number 454778, Kit Catalog Number 112219, and SMN 10310026. The recall is due to trace metal contamination in the Acid Reagent bottles, which resulted in the bottles swelling.
The affected kits were distributed worldwide, including in the United States, Canada, Argentina, China, Colombia, Korea, Malaysia, New Zealand, Mexico, Guatemala, and Singapore. The product is intended for in vitro diagnostic use as a component of the ADVIA Centaur and ADVIA Centaur XP instruments.
The FDA has classified this recall as Class II. Users should stop using the affected kits and contact Siemens Healthcare Diagnostics, Inc. for further instructions.
The recalled product
- Product
- 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…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 3,839
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Kit Lot Number: 454779 Exp. Date: 28 February
- 2015
Distribution
Distributed nationwide across the United States.
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