IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.

FDA device recall Z-1887-2024 · posted 2024-05-23 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab.

Action taken

On April23, 2024, Urgent Medical Device Correction letters were sent to customers. Customer Actions: 1. Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable. 2. Perform the following: Discontinue use of and discard the kit lots listed in the Products Table. You may request no-charge replacement product from your local Siemens Healthineers or distributor office. Please review your inventory of these products to determine your laboratory s replacement needs and to provide information to Siemens Healthineers for reporting to the authorities. Complete and return the Field Correction Effectiveness Check and indicate product replacement needs on the form attached to this letter within 30 days. Please retain this letter with your laboratory records and forward this letter to those who may have received this product.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JZO

Quantity affected

488 units (33 US, 455 OUS)

Distribution

Worldwide - US Nationwide distribution including in the states of AL, CA, DC, FL, HI, ID, IN, KS, KY MA, MI, MN, MO, NC, NJ, NY, OH, OR, PA, PR, TX, WA WI and the countries of Argentina, Australia, Au

Date initiated

2024-04-23

Date posted

2024-05-23

Location

East Walpole, MA

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