Recall Z-0039-2017 ยท CIC Cresolphthalein Complexone, Calcium
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060BB
| Date | Oct 4, 2016 (initiated Aug 3, 2016) |
| Status | Terminated |
| Reason | Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well sets. |
| Root cause | Under Investigation by firm |
| Action | Siemens mailed on August 09, 2016, an Urgent Medical Device Recall letter to all customers who purchased the CA lot 16060BB. The notification letter requested that customers discontinue use and discard the affected kit. |
| Quantity | 5,991 cartridges |
| Distribution | Distributed Nationwide and the countries of : Austria, Bahamas, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Japan, Netherlands, Portugal, Saudi Arabia, South Korea, Slovenia, and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061792 | DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI Dade Behring, Inc., Jul 18, 2006 |