The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2047-2013·Announced 2013-09-04

Siemens PSA Assay Kits Recalled for Positive Bias in Results

Siemens Healthcare Diagnostics is recalling PSA Assay kits for use in IMMULITE systems due to a confirmed positive bias of 20% to 23% in patient results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a systematic measurement error (positive bias) rather than a direct physical injury or acute contamination, fitting the criteria for moderate severity.

Plain-English summary

Siemens Healthcare Diagnostics is recalling 24,361 PSA Assay kits intended for use in IMMULITE/IMMULITE 1000 and IMMULITE 2000/2000 XPi Systems Analyzers. The affected products include various catalog numbers and lot sizes, distributed worldwide including the United States and numerous international markets.

The recall was initiated after customers reported a positive bias in patient results when using these assays compared to the IMMULITE 3rd Generation PSA assay. Siemens confirmed an overall average positive bias of approximately 20% to 23% across the assay range relative to the WHO 96/670 standard. This bias affects patient values and Siemens Tumor Marker controls, and may also be observed with other commercially available controls.

Healthcare facilities and laboratories that possess these specific PSA Assay kits should stop using them and contact Siemens Healthcare Diagnostics for further instructions on the recall process.

The recalled product

Product
PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200…
Manufacturer
Siemens Healthcare Diagnostics
Category
Medical Device — In Vitro Diagnostic
Hazard
Affected units
24,361

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Product Code/Lot # LKPS1 424
  • Expiration Date 2013-08-31
  • Product Code/Lot # LKPS1 425
  • Expiration Date 2013-10-31
  • Product Code/Lot # LKPS1 426
  • Product Code/Lot # LKPS5 424
  • Product Code/Lot # LKPS5 425
  • Product Code/Lot # LKPS5 426
  • Product Code/Lot # LKPTS1(D) D0104
  • Product Code/Lot # L2KPS2 379
  • Expiration Date 2013-07-31
  • Product Code/Lot # L2KPS2 380
  • Product Code/Lot # L2KPS2 381
  • Product Code/Lot # L2KPS2 382
  • Product Code/Lot # L2KPS2 383
  • Product Code/Lot # L2KPS2 384
  • Product Code/Lot # L2KPS6 379
  • Product Code/Lot # L2KPS6 380
  • Product Code/Lot # L2KPS6 381
  • Product Code/Lot # L2KPS6 382

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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