Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported August 2, 2017
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
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. Whil…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Fisher Diagnostics recalled Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 … - a moderate-severity action.
Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 … was recalled by Fisher Diagnostics in August 2, 2017. Reason: An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 10…. Check the official notice for the remedy. Verify recall #Z-2763-2017 with the FDA Devices before acting.
The recall
Fisher Diagnostics issued this moderate-severity FDA Devices recall-An issue was discovered with the Pacific Hemostasis Fibrinogen Degradation Products (FDP) kit, list number 10….
- Moderate
- severity level
- 27 units
- affected scope
- Class II
- classification
- August 2, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2763-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2763-2017) was formally reported on August 2, 2017, with the manufacturer initiating the action on May 19, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Fisher Diagnostics is listed as the recalling firm, operating out of Middletown, VA. Federal records list the affected scope as 27 units.
The documented reason for this recall is: 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 con… Distribution data in the federal record shows the product reached: USA (nationwide) including Puerto Rico, and Internationally to Colombia. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
27 units
Related Recalls
6
3 from same agency
Product description
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 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2763-2017 |
| Date reported | August 2, 2017 |
| Date initiated | May 19, 2017 |
| Recalling firm | Fisher Diagnostics |
| Firm location | Middletown, VA |
| Affected scope | 27 units |
| Distribution | USA (nationwide) including Puerto Rico, and Internationally to Colombia |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2763-2017) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fisher Diagnostics. Units affected: 27 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on August 2, 2017. Severity: Moderate. Recall number: Z-2763-2017.
Where was the recalled product distributed? ▼
Distribution: USA (nationwide) including Puerto Rico, and Internationally to Colombia.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2763-2017) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 2, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.