Recall Z-1540-2018 ยท CIC Cresolphthalein Complexone, Calcium
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN # 10445160 The CA method is an in vitro diagnostic test for the quantitative measurement of calcium in human serum, plasma, and urine on the Dimension Vista System.
| Date | Jan 30, 2018 |
| Status | Terminated |
| Reason | May produce erroneously low results from specific well sets. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Recall and an Urgent Field Safety Notice were issued on January 30, 2018 to all Dimension Vista customers who purchased the impacted lot to notify them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to: "Discontinue use of and discard the Dimension Vista Calcium Flex reagent lot 17171BD. "Please review this letter with your Medical Director. "Review your inventory of these products to determine your laboratorys replacement needs and to provide information to Siemens for reporting to the authorities. "Com |
| Quantity | 6000 |
| Distribution | Worldwide Distribution - USA (nationwide) and to the following countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Italy, Japan, Norway, Portugal, Slovakia, Slovenia, South Korea, Spain, Switzerland |
| 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 |