Instrumentation Laboratory: Medical Device Recall in 2021 - (Recall #: Z-0276-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

Product Classification:

Class II

Date Initiated: October 13, 2021

Date Posted: December 1, 2021

Recall Number: Z-0276-2022

Event ID: 88930

Reason for Recall:

The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.

Status: Ongoing

Product Quantity: 5828 kits (310 US)

Code Information:

Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AZ, CA, IA, IL, KS, ME, MI, NC, NY, OK, SC, and VA. The countries of Canada, Chile, China, Costa Rica, Italy, Japan, and South Korea. ***Updated 3/3/22*** Expansion includes states of IN, MN, and NC.

Voluntary or Mandated:

Voluntary: Firm initiated