Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Si

FDA device recall Z-1648-2022 · posted 2022-08-29 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.

Action taken

Siemens issued US Customers Urgent Medical Device Correction (VC-22-02.A.US) and OUS Customers Urgent Field Safety Notice (VC-22-02.A.OUS) dated July 2022 to inform them to use lot specific correlation factors with all in-date lots of Dimension Vista CA15-3. Letter states reason for recall, health risk and action to take: Calibrate/Recalibrate Dimension Vista LOCI CA 15-3 lots listed in Table 1 using any in date lot of Dimension Vista LOCI 7 Calibrator (SMN 10488446/ REF KC605). Enter lot specific correlation factors C0 and C1 in the Method Configuration screen per Flex reagent Lot listed below in Table 2. After applying correlation factors to the specified lot, product claims listed in the Instructions For Use (IFU) are met For instructions on entering correlation factors please refer to the Dimension Vista System Operator s Guide Rev A 2017-03 or online iGuide (Advanced Functions Section); Method Configuration, Section 9, page 9-25. Process Quality Control (QC) after recalibration and entry of lot specific correlation factors. The correlation factors may create an upward QC shift. Please follow your current laboratory process for adjusting QC ranges. Siemens is providing some examples of CA15-3 lot specific QC values calculated for the three in-date lots of Dimension Vista LOCI CA15-3. CA 15-3 lot specific bottle values for representative sets of QC materials are shown in Table 3. Correlation Factors will remain in the LOCI CA 15-3 Method configuration until removed manually or revised by the user. You may receive future shipments of lots listed in Table 1. Be sure to retain this letter in order to apply correlation factors to CA15-3 lots listed in Table 1. Subsequent lots may require correlation factors. An Alert Card will be included in the subsequent lots with the lot specific correlation factors and lot specific QC. Please review this letter with your Medical Director. If you have any questions, please contact your Siemens Healthineers Customer

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MOI

Quantity affected

129 units US; 159 units OUS

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.

Date initiated

2022-07-18

Date posted

2022-08-29

Location

Newark, DE

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