Recall Z-0611-2019 ยท GFO Activated Partial Thromboplastin
Diagnostica Stago, Inc.
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).
| Date | Nov 14, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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: Donald.kraft@us |
| Quantity | 22342 total |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923731 | STACLOT LA TEST KIT American Bioproducts Co., Dec 23, 1992 |