PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in t

FDA device recall Z-2047-2013 · posted 2013-08-23 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics

Reason for recall

Customers complained of a positive bias in patient results on the IMMULITE/ IMMULITE 1000 and the IMMULITE 2000/ 2000 XPi PSA assay when compared against the IMMULITE /IMMULITE 1000 3rd Generation PSA assay. Siemens has confirmed an overall average positive bias of approximately 20% to 23% across the assay range relative to the WHO 96/670 with the IMMMULITE Systems PSA Assay. This positive bias is observed in patient values and the Siemens Tumor Marker controls (TMCO). Other commercially available controls may show this bias.

Action taken

Seimens sent an Urgent Medical Device Recall Letters to US consignees via FedEx and an Urgent Field Safety Notices were sent to the foreign consignees starting on June 26, 2013. In addition, Support Bulletins were distributed to Siemens Healthcare Diagnostics service personnel describing the issue and instructing them how to deal with customer questions. Customers were informed to discontinue use, discard the kits remaining in inventory and there are no replacement PSA kits available at this time. Siemens is instructing customers to contact their local Siemens representative for assistance with determining appropriate PSA testing solutions for your laboratory.

Root cause

Software design

Status

Terminated

Product code

MFT

Quantity affected

24,361 kits

Distribution

Worldwide Distribution - USA Nationwide including Puerto Rico and the countries of: Albania, Afghanistan, Algeria, Argentina, Austria, Bangladesh, Belgium, Bolivia, Bosnia- Herzegovinia, Brazil, Bulga

Date initiated

2013-06-26

Date posted

2013-08-23

Date terminated

2017-02-28

Location

Tarrytown, NY