FDA Device recall Z-2763-2017
Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD
- FDA Device
- Class II
- terminated
- Published 2017-08-02
On 2017-08-02 the FDA classified a Class II recall of Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD by Fisher Diagnostics, citing an issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2763-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-19 |
| Published | 2017-08-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fisher Diagnostics |
| Distribution | US |
Product
Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
Reason
An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100650, lot 948546 and FDP Latex Reagent, list 100651, lot 890199. While the kit performs accurately at FDP concentrations greater than 20 ¿g/ml, there is an observed reduction in sensitivity when FDP levels are less than 20 ¿g/ml. This reduction in sensitivity has been tied to FDP Latex Reagent lot 890199 and may result in false negatives.
Identifiers
| code_info | Lot Number 890199, Exp. 6/30/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2763-2017%22
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