Recall Z-1052-2022— Instrumentation Laboratory

Name: FDA recall Z-1052-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-08

Class II · Ongoing

Class II FDA medical device recall by Instrumentation Laboratory, initiated 2022-04-08. It names one FDA 510(k) clearance: K122584. Product: HemosIL ReadiPlasTin, Part No. 0020301400. Reason: 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..

Recalling firm: Instrumentation Laboratory
Classification: Class II
Status: Ongoing
Initiated: 2022-04-08
Firm location: Bedford, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K122584 — HEMOSIL READIPLAS TINInstrumentation Laboratory CO·cleared 2013-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HemosIL ReadiPlasTin, Part No. 0020301400

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.