Diagnostica Stago, Inc. recalls Staclot LA 20 (REF 00594) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative…
- Recall date
- November 14, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0611-2019
- FDA classification
- Class II
- Brand / firm
- Diagnostica Stago, Inc.
- Sold / distributed
- US Nationwide Distribution
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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).
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