Staclot LA Test Kit

• 2 recalls, same reason

  • Terminated Z-0611-2019 FDA Class II ·initiated 14 Nov 2018
  • Terminated Z-0610-2019 FDA Class II ·initiated 14 Nov 2018

  There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.

• • Terminated Z-1441-06 FDA Unclassified (pre-2012) ·initiated 18 Jul 2006

  Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.

510(k) Number

K923731 ↗

FDA Product Code

GFO

Device Class

Class II

Regulation

21 CFR Part 864.7925

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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See all devices from American Bioproducts Co. →

• What is the primary clinical use of the Staclot LA Test Kit?

  The Staclot LA Test Kit is an activated partial thromboplastin device specifically designed for use in hematology applications to assist in the laboratory assessment of coagulation parameters.

• What is the regulatory status of this device?

  The Staclot LA Test Kit is a class 2 medical device that received FDA 510(k) clearance under K923731, confirming it was found to be substantially equivalent to other devices for its intended use.

• Who is the manufacturer of the Staclot LA Test Kit?

  This device is manufactured by American Bioproducts Co., located in Parsippany, New Jersey, and is categorized under the hematology medical specialty.