Device 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).
Z-0611-2019
Product summary
- Event
- Event 81678
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22342 total
- Official record key
device-enforcement:Z-0611-2019
Official wording
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.
Code information: Lot #s 251504, 251916, 252243, 252364, 252887, 253211
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
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.