Pacific Hemostasis FDP — Class II medical device recall Z-2762-2017
Terminated recall by Fisher Diagnostics, reported 2017-08-02, distributed nationwide. An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 100
| Recall number | Z-2762-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fisher Diagnostics, Middletown, VA, United States |
| Recall initiated | 2017-05-19 |
| Classified | 2017-07-25 |
| Reported by FDA | 2017-08-02 |
| Terminated | 2018-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CO |
| Quantity | 331 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00845275000863 |
| Lot numbers | 948546 |
| Model numbers | 100650 |
| Expiration dates | 2017-09-30 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2762-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.