Recall Z-1927-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Siemens Healthcare Diagnostics, Inc
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
| Date | Jun 26, 2014 (initiated Jun 2, 2014) |
| Status | Terminated |
| Reason | Swollen acid bottles due to a trace metal contamination in the Acid Reagent bottles |
| Root cause | Material/Component Contamination |
| Action | Siemens Healthcare Diagnostics issued Urgent Medical Device Recall (UMDR) to customers in the United States on June 02, 2014 and a Urgent Field Safety Notice (UFSN) issued outside the United States on June 02, 2014. These notices inform the customer of the potential for swollen acid bottles due to confirmed metal contamination. Customers with alternative lots in inventory were instructed to transition to the alternative lot upon receipt of the communication. Customers without an alternative lot of acid in inventory were informed that Siemens proactively shipped an alternative lot to their lab |
| Quantity | 3,839 kits |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Canada, Argentina, China, Colombia, Korea, Malyasia, New Zealand, Mexico, Guatemala, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.