—#162736

Product

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 product code: CIC — Cresolphthalein Complexone, Calcium
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K061792
Affected lot / code info: Lot # 17171BD, UDI # (UDI) 0084276801561817171BD18062010445160 EXP. 06-20-2018

Why it was recalled

May produce erroneously low results from specific well sets.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 500 Gbc Dr Po Box 6101, Ms 514, Newark, Delaware 19702-2466

Distribution

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

Timeline

Recall initiated: 2018-01-30
Terminated: 2019-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #162736. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.