Instrumentation Laboratory: Medical Device Recall in 2026 - (Recall #: Z-1095-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

Product Classification:

Class II

Date Initiated: December 11, 2025

Date Posted: January 21, 2026

Recall Number: Z-1095-2026

Event ID: 98166

Reason for Recall:

Potential for microbial contamination.

Status: Ongoing

Product Quantity: 7,720 units

Code Information:

Part Number: 0020006800. UDI-DI: 08426950078920. Lot Number: N1136730. Expiration Date 12/31/2025.

Distribution Pattern:

Worldwide - US Nationwide distribution in the states of CA, FL, IL, MN, MS, NE, OH, TX, WI and the countries of Belgium, Netherlands, Luxembourg, Switzerland, China, Hong Kong, Israel, Italy, South Korea, Lithuania, Macao, Malaysia, Philippines, Qatar, Romania, Turkey, Kosovo.

Voluntary or Mandated:

Voluntary: Firm initiated