Recall Z-1927-2014— Siemens Healthcare Diagnostics, Inc
Class II · Terminated
Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc, initiated 2014-06-02, terminated 2015-02-05. FDA's recall record names no specific 510(k) clearance for this event. 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 instruments. Reason: Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles.
- Recalling firm
- Siemens Healthcare Diagnostics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-02
- Terminated
- 2015-02-05
- Firm location
- East Walpole, MA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.