FDA Device recall Z-2762-2017
Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, 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 (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, 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-2762-2017 |
| 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 (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.
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 948546, Exp. 9/30/2017 |
|---|
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-2762-2017%22
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