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Dimension Cardiac Troponin-I Flex reagent cartridge recallZ-1340-2022 · Siemens Healthcare Diagnostics, Inc. · initiated May 18, 2022

Terminated

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

Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 g/L], may lead to inappropriate intervention for myocardial infarction

FDA root cause category: Under Investigation by firm

What the company is doing

****Recall Expanded 9-21-22*** US Customers were sent Urgent Medical Device Correction (DC-22-2.B.US) on 09/21/2022 and an Urgent Field Safety Notice UFSN DC-22-02.B.OUS) was issued to all OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 09/26/2022. Letter informs them to use serum patient samples only when utilizing lot BA3088. Laboratories unable to use serum patient samples for testing are to request a no charge replacement for their impacted reagent. Siemens issued Urgent Medical Device Correction (UMDC) to US affected customers by FedEx beginning on 05/18/2022. An Urgent Field Safety Notice (UFSN) was issued to all OUS Siemens reporting sites for distribution and regional reporting to their local competent authorities beginning on 05/18/2022. Letter states reason for recall, health risk and action to take: Please review this letter with your Medical Director. Siemens recommends using serum patient samples only when using the lots listed in Table 1. If your laboratory is not able to use serum samples, please discard the reagent and complete the attached Product Replacement form for a no-charge replacement product. Review your inventory to determine possible replacement needs and to provide information to Siemens for reporting to the Authorities. 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. If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers Technical Support Representative.

Recall details

Recall number
Z-1340-2022
Status
Terminated
Initiated by the company
May 18, 2022
Posted by the FDA
Jul 6, 2022
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
76 units
Product code
MMI
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, IL MN, MS, NC, ND, NH, OK, SD, TN, TX, WA and the countries of Argentina, Brazil, Canada, France, Germany, India, Mexico, Poland, Portugal, Slovakia, Spain.

Product description

Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521

Code information (models, lots, serial numbers)

UDI-DI: 00842768013904EA231420221110 Lot Number: EA2314 Exp. Date: 11-10-2022

Devices named in this recall

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

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 90387).

Sources and updates

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