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U.S. Department of Health and Human Services

Class 2 Device Recall HemosIL ReadiPlasTin

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  Class 2 Device Recall HemosIL ReadiPlasTin see related information
Date Initiated by Firm October 13, 2021
Date Posted November 23, 2021
Recall Status1 Open3, Classified
Recall Number Z-0276-2022
Recall Event ID 88930
510(K)Number K122584  
Product Classification Test, time, prothrombin - Product Code GJS
Product HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Code Information Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224
Recalling Firm/
Manufacturer		 Instrumentation Laboratory
180 Hartwell Rd
Bedford MA 01730-2443
For Additional Information Contact IL Technical Support Center
800-678-0710
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by 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.
Quantity in Commerce 5828 kits (310 US)
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GJS and Original Applicant = INSTRUMENTATION LABORATORY CO.
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