HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
FDA Recall Z-0276-2022 · Posted 2021-11-23
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Recalling FirmInstrumentation Laboratory
Recall StatusOpen, Classified
Product CodeGJS
Date Initiated2021-10-13
Product Quantity5828 kits (310 US)
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.
Firm Action
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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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