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.
FDA Recall Z-1540-2018 · Posted None
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Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeCIC
Date Initiated2018-01-30
Date Terminated2019-05-16
Product Quantity6000
Reason for Recall
May produce erroneously low results from specific well sets.
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.
"Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.
If you have received any complaints of illness or adverse events associated with the product listed in Table 1, immediately contact your local Siemens Customer Care Center or your local Siemens Technical Support Representative. For further questions, please call (312) 275-7795.
Root Cause
Under Investigation by firm
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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