IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

FDA device recall Z-0464-2025 · posted 2024-11-14 · Open, Classified

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in the Instructions for Use (IFU).

Action taken

An Urgent Medical Device Correction letter dated 9/30/24 was sent to customers. Customer Actions " Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, that may have been affected. " Complete and return the Field Correction Effectiveness Check 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. Resolution IMMULITE 2000 and IMMULITE 2000 XPi kit lots D168 and above meet the IFU high-dose hook effect claim. Siemens continues to investigate root cause of the issue observed with the impacted kit lots. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please send a scanned copy of the completed form via email to uscctsfcaecfax.team@siemens-healthineers.com. Or to fax this completed form to the Customer Care Center at (312) 275-7795.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

MTF

Quantity affected

7,332 units

Distribution

Worldwide - US Nationwide distribution.

Date initiated

2024-09-30

Date posted

2024-11-14

Location

East Walpole, MA