Diagnostica Stago, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0611-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus anticoagulants (LA) in plasma by the use of hexagonal HII phase phospholipid molecules (1, 2).

Product Classification:

Class II

Date Initiated: November 14, 2018

Date Posted: December 26, 2018

Recall Number: Z-0611-2019

Event ID: 81678

Reason for Recall:

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.

Status: Terminated

Product Quantity: 22342 total

Code Information:

Lot #s 251504, 251916, 252243, 252364, 252887, 253211

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated