Class IIReported 2026-01-21

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

Recalled by Instrumentation Laboratory

Reason for Recall

Potential for microbial contamination.

Recall Number

Z-1095-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-12-11

Reported

2026-01-21

Distribution

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.

Code Info

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

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.