Recall Z-0276-2022— Instrumentation Laboratory

Name: FDA recall Z-0276-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-13

Class II · Ongoing

Class II FDA medical device recall by Instrumentation Laboratory, initiated 2021-10-13. It names one FDA 510(k) clearance: K122584. Product: HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.. Reason: 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..

Recalling firm: Instrumentation Laboratory
Classification: Class II
Status: Ongoing
Initiated: 2021-10-13
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 (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

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.

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