| | Class 2 Device Recall STA Liatest DDi |  |
| Date Initiated by Firm | February 05, 2026 |
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| Date Posted | March 19, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1585-2026 |
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| Recall Event ID |
98362 |
| 510(K)Number | K162227 |
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| Product Classification |
Fibrinogen and fibrin split products, antigen, antiserum, control - Product Code DAP
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| Product | Brand Name: STA Liatest D-Di
Product Name: STA Liatest D-Di
Model/Catalog Number: REF 00515
Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by
professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT.
Component: No |
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| Code Information |
Model/Catalog Number: REF 00515;
UDIs: (1) (01)03607450005158(11)240630(17)250930(10)273015(241)00515, (2) (01)03607450005158(11)250325(17)260630(10)273127(241)00515, (3)(01)03607450005158(11)250416(17)260731(10)273275(241)00515, (4)(01)03607450005158(11)250527(17)260831(10)273567(241)00515, (5)(01)03607450005158(11)250618(17)260930(10)273681(241)00515, (6)(01)03607450005158(11)250716(17)261031(10)273808(241)00515, (7)(01)03607450005158(11)250716(17)261231(10)273808(241)00515, (8)(01)03607450005158(11)250909(17)261231(10)274108(241)00515 (9) (01)03607450005158(11)250326(17)260630(10)273128(241)00515, (10) (01)03607450005158(11)250429(17)260731(10)273606(241)00515, (11) (01)03607450005158(11)250709(17)261031(10)273805(241)00515, (12) (01)03607450005158(11)251007(17)270131(10)274219(241)00515;
Lot numbers: (1)273015, (2)273127, (3)273275, (4)273567, (5)273681, (6)273808, (7)273995, (8)274108, (9)273128, (10)273606, (11)273805, (12)274219;
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| FEI Number |
2245451
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Recalling Firm/
Manufacturer |
Diagnostica Stago, Inc.
5 Century Dr
Parsippany NJ 07054-4607
|
| For Additional Information Contact | Technical Hotline
800-7250607 |
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Manufacturer Reason
for Recall | After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. |
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FDA Determined
Cause 2 | Process change control |
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| Action | On February 5, 2026 QUALITY ALERT letters were emailed to customers.
Actions required:
1. As the intended purpose of the kit is to exclude PE and DVT, and its sensitivity and negative predictive value remain unchanged, it is appropriate to continue utilizing the reagents.
2. Please complete, sign and return the attached Acknowledgement Form by email, as directed on the form.
In the event that a patient experiences an adverse event with any medical device, you may report it to FDA; see the guidance document Medical Device Reporting for User Facilities, which is available on the FDA.gov website, for instructions.
For additional information, please contact Stago s 24/7 Hotline at 1-800-725-0607.
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| Quantity in Commerce | 34000 units (28446 US, 5554 OUS) |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Singapore, Guam, Japan, South Korea, and Russia. |
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| Total Product Life Cycle | TPLC Device Report |
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = DAP
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