CLASS II Device recall · Reported 2 Aug 2017 · FDA Enforcement Report
Pacific Hemostasis FDP Latex Reagent recalled by Fisher Diagnostics
Fisher Diagnostics is recalling Pacific Hemostasis FDP Latex Reagent, distributed nationwide in the US. The recall was initiated on 19 May 2017 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-2763-2017
- FDA event ID
- 77340
- Recalling firm
- Fisher Diagnostics, Middletown, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 May 2017
- FDA classified
- 25 Jul 2017
- Reported
- 2 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 19 May 2017 | Recall initiated by company | |
| 25 Jul 2017 | Classified by FDA | +67 days |
| 2 Aug 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
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 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
Where it was distributed
USA (nationwide) including Puerto Rico, and Internationally to Colombia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot Number 890199, Exp. 6/30/2018
Where was it sold?
USA (nationwide) including Puerto Rico, and Internationally to Colombia
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 77340This product is part of a recall event; the main page for the event is Pacific Hemostasis FDP (Fibrinogen Degradation Products) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pacific Hemostasis FDP (Fibrinogen Degradation Products) recalled | Fisher Diagnostics | Potency & Assay | Nationwide |
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 Thromboplastin-D Used recalled by Fisher Diagnostics | Fisher Diagnostics | Potency & Assay | PA |
| Device | CLASS II | Pacific Hemostasis FDP (Fibrinogen Degradation Products) recalled | Fisher Diagnostics | Potency & Assay | Nationwide |
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