Recall Z-0077-2019— Instrumentation Laboratory Co.
Class II · Terminated
Class II FDA medical device recall by Instrumentation Laboratory Co., initiated 2018-08-01, terminated 2019-04-16. It names one FDA 510(k) clearance: K122584. Product: Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.. Reason: There is a potential for increased imprecision, out of range quality controls and prolonged sample results..
- Recalling firm
- Instrumentation Laboratory Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-01
- Terminated
- 2019-04-16
- Firm location
- Bedford, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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
Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL¿ ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP¿ Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Reason for recall
There is a potential for increased imprecision, out of range quality controls and prolonged sample results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.