CLASS II ONGOING Device recall · Reported 9 Apr 2025 · FDA Enforcement Report
Pacific Hemostasis Thromboplastin-D Used recalled by Fisher Diagnostics
Fisher Diagnostics is recalling Pacific Hemostasis Thromboplastin-D Used in performing one-stage prothrombin time test, distributed in Pennsylvania. The recall was initiated on 6 Mar 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1503-2025
- FDA event ID
- 96488
- Recalling firm
- Fisher Diagnostics, Middletown, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Mar 2025
- FDA classified
- 31 Mar 2025
- Reported
- 9 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 6 Mar 2025 | Recall initiated by company | |
| 31 Mar 2025 | Classified by FDA | +25 days |
| 9 Apr 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Pacific Hemostasis Thromboplastin-D, 10 ml. Used in performing one-stage prothrombin time test and factor assays.
Where it was distributed
US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
Questions about this recall
Is Pacific Hemostasis Thromboplastin-D Used in performing one-stage prothrombin time test recalled?
Yes. Fisher Diagnostics recalled Pacific Hemostasis Thromboplastin-D Used in performing one-stage prothrombin time test on 6 Mar 2025. The recall is Class II and its status is Ongoing. Recall number Z-1503-2025.
Why was it recalled?
The incorrect value of the International Sensitivity Index (ISI) is printed on the outer box label.
Which lots are affected?
Catalog No. 100357; UDI: 00845275000798665150270131100357; Lot No. 665150; Exp. Date 01/31/2027.
Where was it sold?
US Distribution to: PA and OUS Foreign country of: United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fisher Diagnostics
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Pacific Hemostasis Thromboplastin-D Used recalled by Fisher Diagnostics | Fisher Diagnostics | Potency & Assay | PA |
| Device | CLASS II | Pacific Hemostasis FDP Latex Reagent recalled by Fisher Diagnostics | Fisher Diagnostics | Potency & Assay | Nationwide |
| Device | CLASS II | Pacific Hemostasis FDP (Fibrinogen Degradation Products) recalled | Fisher Diagnostics | Potency & Assay | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,656| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | STA Staclot Protein S recalled by Diagnostica Stago | Diagnostica Stago | Potency & Assay | Nationwide |
| Device | CLASS II | DxC 500i Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | DxC 500 AU Clinical Analyzer Modules using recalled by Beckman Coulter | Beckman Coulter | Packaging Defects | Nationwide |
| Device | CLASS II | Syva EMIT 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Beckman Coulter, Emit 2000 Quinidine Assay recalled | Siemens Healthcare Diagnostics | Lead & Heavy Metals | Nationwide |