The Recall Desk
ModerateFDA (Devices)·Z-1073-2013·Announced 2013-04-17

Siemens Recalls Dade Actin FSL Activated PTT Reagent Due to Heparin Sensitivity

Siemens Healthcare Diagnostics is recalling specific lots of Dade Actin FSL Activated PTT Reagent because they show increased heparin sensitivity over their shelf life.

What this means for you

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 source text describes a performance deviation (increased heparin sensitivity) without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or performance issues without reported harm.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling 13,083 units of Dade(R) Actin(R) FSL Activated PTT Reagent. This product is used in laboratories to determine the activated partial thromboplastin time (APTT). The recall involves catalog numbers B4219-1 and B4219-2, specifically lot numbers 547311, 547312, and 547316A.

The recall was initiated because Siemens observed that the listed lot numbers show an increase in heparin sensitivity over the shelf life. This issue was demonstrated through testing with Dade(R) Citrol(R) Heparin Control, low and high. The affected products were distributed nationwide in the United States, including Puerto Rico, and in Canada.

Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on how to return the product. Consumers do not use this product directly; it is intended for professional laboratory use.

The recalled product

Product
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial thromboplastin time (APTT).
Manufacturer
Siemens Healthcare Diagnostics, Inc.
Category
Medical Device — Laboratory Reagent
Hazard
Affected units
13,083

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 (5)

  • Catalog numbers B4219-1 and B4219-2: lot numbers 547311
  • exp 3/22/2013
  • 547312
  • exp 3/22/2013 and 547316A
  • exp 4/28/2013.

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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Same hazard · performance deviation

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