Recall Z-1887-2024 ยท JZO System, Test, Thyroid Autoantibody
Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
| Date | May 23, 2024 (initiated Apr 23, 2024) |
| Status | Open, Classified |
| Reason | The potential for falsely elevated patient sample results when using impacted lots (785, 790, 791, and 793) of IMMULITE 2000 Anti-TG Ab. |
| Root cause | Under Investigation by firm |
| Action | 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 |
| Quantity | 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, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991094 | IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 Diagnostic Products Corp., May 13, 1999 |