| Date Initiated by Firm | November 14, 2018 |
|---|
| Create Date | December 14, 2018 |
|---|
| Recall Status1 |
Terminated 3 on June 08, 2020 |
| Recall Number | Z-0610-2019 |
|---|
| Recall Event ID |
81678 |
| 510(K)Number | K923731 |
|---|
| Product Classification |
Activated partial thromboplastin - Product Code GFO
|
| Product | Staclot LA (REF 00600)
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). |
|---|
| Code Information |
Lot #s 251918, 252751 |
| FEI Number |
2245451
|
Recalling Firm/
Manufacturer |
Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
|
| For Additional Information Contact | Stago Hotline
973-631-1200 |
|---|
Manufacturer 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. |
|---|
FDA Determined
Cause 2 | 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.stago.com or 1-973-631-1200 ext 4104. |
|---|
| Quantity in Commerce | 22342 total |
|---|
| Distribution | US Nationwide Distribution |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = GFO
|
|---|
