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Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro… recallZ-1258-2023 · Siemens Healthcare Diagnostics, Inc. · initiated Jan 30, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and GA3171. The health consequences of erroneous patient results are major, since in a worst case scenario, a patient s tacrolimus dosing could be altered, resulting in potential organ failure and rejection (due to too low or no tacrolimus being administered) or toxicity (due to too much tacrolimus being administered). Siemens internal investigation of the Dimension TAC assay showed the worst case imprecision with patient samples at the low end of the Analytical Measurement Range (AMR). A patient sample at 2.0 ng/mL (2.6 nmol/L) recovered as 0.0 ng/mL (0.0 nmol/L) (100% negative bias), another patient sample at 2.1 ng/mL (2.7 nmol/L) recovered at 4.3 ng/mL (5.6 nmol/L) (103% positive bias).

FDA root cause category: Under Investigation by firm

What the company is doing

Siemens issued to US Customers Urgent Medical Device Correction (DC-23-03.A.US) via FedEx beginning on 01/30/2023. OUS Customers sent Urgent Field Safety Notice (DC-23-03.A.OUS). Letter states reason for recall, health risk and action to take: Discontinue use and discard the lots listed in Table 1 and complete the attached Product Replacement form for no-charge product replacement. Please note, lot GA2286 is expired. Review your inventory to determine possible replacement needs and provide information to Siemens for reporting to the Authorities. Please review this letter with your Medical Director and the decision on a review of previously generated results. If you receive any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Remote Services Center or your local Siemens Technical Support Representative. Complete and return the Field Correction Effectiveness Check/Product Replacement Form attached to this letter within 30 days to Siemens Healthineers for reporting to the Authorities. Questions, contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative.

Recall details

Recall number
Z-1258-2023
Status
Open, Classified
Initiated by the company
Jan 30, 2023
Posted by the FDA
Mar 15, 2023
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
6035 units
Product code
MLM
FDA submissions
K150168
Distribution
Worldwide and Nationwide Distribution Foreign: Aregentina Brazil Chile Colombia Country India Japan New Zealand Nicaragua Saudi¿Arabia¿¿¿ South Africa South Korea Spain¿¿¿¿¿¿¿¿¿¿ Sri Lanka Taiwan

Product description

Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension clinical chemistry system SMN: 10700795 (DF207)

Code information (models, lots, serial numbers)

UDI: 00842768035425GA228622101310700795840, 00842768035425GA304723021610700795840, 00842768035425GA317123062010700795840. Lot Numbers: GA2286, GA3047, GA3171

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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