HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Check against the official notice below — it lists the full affected range.
Instrumentation Laboratory has recalled HemosIL ReadiPlasTin (20 mL), Part number 0020301400, a reagent used in blood clotting tests. The company received reports of performance problems with certain lots, including increased imprecision, quality control failures, and prolonged test results. If quality control tests are not performed or fail for each vial, there is a potential risk that erroneous blood clotting results could be reported to patients.
The recall affects 5,828 kits distributed worldwide, with 310 kits distributed in the United States across multiple states, as well as in Canada, Chile, China, Costa Rica, Italy, Japan, and South Korea. The affected lots are N0705526 (UDI: 08426950632887) and N0806224. The source does not specify what action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: 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. Quantity: 5828 kits (310 US) Lot/code info: Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.