Instrumentation Laboratory HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Brand
Instrumentation Laboratory
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224
Instrumentation Laboratory is recalling HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent due to The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, an. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On October 13, 2021, the firm sent customers Urgent Medical Device Removal letters via email. These emails were followed by certified letters sent starting the same day. ***On February 17, 2022, the firm expanded the recall to include an additional lot of product.*** The customers were provided with instructions to run quality controls with each vial. Customers should discard any vials with failed quality controls. For technical questions, please contact the IL Technical Support Center at 1-800-678-0710, Option # 2 (ACL Coagulation Products). For alternate lot availability questions, please contact your IL Customer Service Representative at 1-800-955-9525, Option # 0.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026