IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ I
FDA device recall Z-0949-2023 · posted 2023-01-11 · Open, Classified
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Reason for recall
- Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe increased imprecision with low level patient samples
- Action taken
- Siemens Healthcare issued An Urgent Medical Device Correction (UMDC) to US affected customers by FedEx beginning 12/08/2022. An Urgent Field Safety Notice (UFSN) was issued to OUS Siemens reporting sites with affected customers, for distribution and regional reporting to their local competent authorities beginning on 12/07/2022. Letter states reason for recall, health risk and action to take: Discontinue use and discard Thyroglobulin kit lots listed in Table 1. Please review this letter with your Medical Director, including consideration for review of previously generated results as outlined above in Risk to Health. Complete and return Field Correction Effectiveness Check Form attached to this letter within 30 days. Review your inventory of these products determine your laboratory s replacement needs and to provide information 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. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MSW
- Quantity affected
- 717 kits
- Distribution
- Nationwide Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Bahrain¿¿¿¿¿¿¿¿ Bangladesh¿¿¿¿¿ Belgium¿¿¿¿¿¿¿¿ Bolivia¿¿¿¿¿¿¿¿ Bosnia¿Herzeg.¿ Brazil¿¿¿¿¿¿¿¿¿ Bulgaria¿¿¿¿¿¿¿ Canada¿¿¿¿¿¿¿¿¿ Chil
- Date initiated
- 2022-12-07
- Date posted
- 2023-01-11
- Location
- Tarrytown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 THYROGLOBULIN MODEL L2KTY (K982468) | Diagnostic Products Corp. | 1999-03-12 |