Fisher Diagnostics Pacific Hemostasis Thromboplastin-D Recalled for Labeling Error

Agency Publication Date: March 31, 2025

Summary

Fisher Diagnostics is recalling 6,086 units of Pacific Hemostasis Thromboplastin-D because the outer box label contains an incorrect International Sensitivity Index (ISI) value. This laboratory reagent is used to perform prothrombin time tests and factor assays to evaluate blood clotting. Using an incorrect ISI value can lead to inaccurate test results, which may affect clinical decisions and patient treatment. No injuries or incidents have been reported at this time.

Risk

The incorrect label value could cause laboratories to miscalculate test results, potentially leading to incorrect dosing of blood-thinning medications or a failure to identify clotting disorders. This poses a moderate risk to patient safety depending on the clinical setting.

What You Should Do

This recall involves Fisher Diagnostics Pacific Hemostasis Thromboplastin-D laboratory reagents, which are used in blood clotting tests and factor assays.
The recalled products include 4 ml containers (Catalog No. 100356) and 10 ml containers (Catalog No. 100357).
Check your inventory for 4 ml units with Lot Number 719170 (Exp. Date 11/30/26) or 10 ml units with Lot Number 665150 (Exp. Date 01/31/2027).
Stop using the recalled product immediately and secure any remaining stock to prevent further use.
Contact Fisher Diagnostics or your designated distributor to arrange for the return, replacement, or correction of the affected units.
Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Pacific Hemostasis Thromboplastin-D (4 ml)

Variants: 4 ml

Model / REF:

100356

Lot Numbers:

719170 (Exp. Date 11/30/26)

UDI:

00845275000542719170261130100356

Quantity: 4,387 units; Recall #: Z-1502-2025

Product: Pacific Hemostasis Thromboplastin-D (10 ml)

Variants: 10 ml

Model / REF:

100357

Lot Numbers:

665150 (Exp. Date 01/31/2027)

UDI:

00845275000798665150270131100357

Quantity: 1,699 units; Recall #: Z-1503-2025

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96488

Status: Active

Manufacturer: Fisher Diagnostics

Sold By: Fisher Diagnostics distribution channels

Manufactured In: United States

Units Affected: 2 products (4,387 units; 1,699 units)

Distributed To: Pennsylvania

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves Fisher Diagnostics Pacific Hemostasis Thromboplastin-D laboratory reagents, which are used in blood clotting tests and factor assays.

The recalled products include 4 ml containers (Catalog No. 100356) and 10 ml containers (Catalog No. 100357).

Check your inventory for 4 ml units with Lot Number 719170 (Exp. Date 11/30/26) or 10 ml units with Lot Number 665150 (Exp. Date 01/31/2027).

Stop using the recalled product immediately and secure any remaining stock to prevent further use.

Contact Fisher Diagnostics or your designated distributor to arrange for the return, replacement, or correction of the affected units.

Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this recall.

Affected Products

Product: Pacific Hemostasis Thromboplastin-D (4 ml)

Variants: 4 ml

Model / REF:

100356

Lot Numbers:

719170 (Exp. Date 11/30/26)

UDI:

00845275000542719170261130100356

Quantity: 4,387 units; Recall #: Z-1502-2025

Product: Pacific Hemostasis Thromboplastin-D (10 ml)

Variants: 10 ml

Model / REF:

100357

Lot Numbers:

665150 (Exp. Date 01/31/2027)

UDI:

00845275000798665150270131100357

Quantity: 1,699 units; Recall #: Z-1503-2025