FDA-Device2018-12-26Class II
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).
Diagnostica Stago, Inc.
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
22342 total
Manufactured in
5 Century Dr, Parsippany, NJ, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0611-2019Don't want to check this manually?
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