Recall Z-0611-2019— Diagnostica Stago, Inc.

Name: FDA recall Z-0611-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-14

Class II · Terminated

Class II FDA medical device recall by Diagnostica Stago, Inc., initiated 2018-11-14, terminated 2020-06-08. It names one FDA 510(k) clearance: K923731. Product: 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).. Reason: 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..

Recalling firm: Diagnostica Stago, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-11-14
Terminated: 2020-06-08
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K923731 — STACLOT LA TEST KITAmerican Bioproducts Co.·cleared 1992-12-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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).

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.