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).
Recall
- Recall Number
- Z-0611-2019
- Event Number
- 81678
- Firm
- Diagnostica Stago, Inc.
- FEI Number
- 2245451
- Product Code
- GFO
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- November 14, 2018
- Terminated
- June 8, 2020
- Address
- 5 Century Dr, Parsippany, NJ, 07054-4607
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).
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.
The firm, STAGO, sent a "Field Safety Notice" to its customers on 11/14/18. The notices describe the product, problem and actions to be taken. The customers were instructed to do the following: If you have any lots listed in the appendix in your laboratory, stop using and destroy the concerned kits; contact our sales administration team (1-800-222-2624 prompt #3) as soon as possible in order to obtain a replacement lot and complete the attached coupon acknowledging receipt of the letter. For additional information, please contact the STAGO hotline (1-800-725-0607) or email: [email protected] or 1-973-631-1200 ext 4104.
US Nationwide Distribution
22342 total