Instrumentation Laboratory: Medical Device Recall in 2022 - (Recall #: Z-1052-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

HemosIL ReadiPlasTin, Part No. 0020301400

Product Classification:

Class II

Date Initiated: April 8, 2022

Date Posted: May 18, 2022

Recall Number: Z-1052-2022

Event ID: 90012

Reason for Recall:

Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.

Status: Ongoing

Product Quantity: 1,563 (US); 29,046 (OUS)

Code Information:

UDI 08426950632887 All in-date lots are affected by this recall.

Distribution Pattern:

US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV.

Voluntary or Mandated:

Voluntary: Firm initiated