The Recall Desk
ModerateFDA (Devices)·Z-1784-2013·Announced 2013-07-31

Instrumentation Laboratory Recalls HemosIL RecombiPlasTin 2G Coagulation Reagent

Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G reagent kits due to out-of-specification quality issues. The product is used for evaluating the extrinsic coagulation pathway.

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, which typically involves a temporary or medically reversible adverse health consequence. The source text cites 'Out of Specification' as the reason without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Instrumentation Laboratory is recalling specific lots of HemosIL RecombiPlasTin 2G (RPT2G), Part Number 0020002950 (8 ml size), because the product is out of specification. This reagent is used in medical laboratories for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.

The recall covers 12 distributed kits with specific lot numbers and expiration dates ranging from May 31, 2013, to January 31, 2015. Two additional lots were not distributed. The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries.

No specific adverse health events or injuries have been reported in the source text. Users of this product should contact Instrumentation Laboratory for further instructions regarding the return or disposal of the affected lots.

The recalled product

Product
HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
Manufacturer
Instrumentation Laboratory Co.
Category
Medical Device — Laboratory Reagent
Hazard

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 (13)

  • 2) N0817321 Exp. Date 5/31/2013
  • 3) E0917396 Exp. Date 9/30/2013
  • 4)) N0917378 Exp. Date 9/30/2013
  • 5) N1118029 Exp. Date 10/31/2013
  • 6) N0128669 Exp. Date 1/31/2014
  • 7) N0329291 Exp. Date 2/28/2014
  • 8) N0429596 Exp. Date 3/31/2014
  • 9) N0520056 Exp. Date 5/31/2014
  • 10) E0720822 Exp. Date 7/31/2014
  • 11) N0821174 Exp. Date 8/31/2014
  • 12) N091388 Exp. Date 9/30/2014
  • 13) N0921522 Exp. Date 9/30/2014
  • 14) N0132676 Exp. Date 1/31/2015 and 15) N1222567 Exp. Date 1/31/2015.

Distribution

Distributed nationwide across the United States.

The notice also names 41 states specifically:

Related recalls

Same manufacturer · Instrumentation Laboratory Co.

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Same hazard · out of specification

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