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
Reported: July 2, 2014 Initiated: June 2, 2014 #Z-1927-2014
Product Description
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
Reason for Recall
Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc
- Units Affected
- 3,839 kits
- Distribution
- Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore.
- Location
- East Walpole, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Siemens Healthcare Diagnostics, Inc. Units affected: 3,839 kits.
Why was this product recalled? ▼
Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 2, 2014. Severity: Moderate. Recall number: Z-1927-2014.
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