Z-0611-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 26, 2018
- Initiation Date
- November 14, 2018
- Termination Date
- June 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22342 total
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.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot #s 251504, 251916, 252243, 252364, 252887, 253211