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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 April 08, 2022
Create Date May 10, 2022
Recall Status1 Open3, Classified
Recall Number Z-1052-2022
Recall Event ID 90012
510(K)Number K122584  
Product Classification Test, time, prothrombin - Product Code GJS
Product HemosIL ReadiPlasTin, Part No. 0020301400
Code Information UDI 08426950632887 All in-date lots are affected by this recall.
Recalling Firm/
Manufacturer		 Instrumentation Laboratory
180 Hartwell Rd
Bedford MA 01730-2443
For Additional Information Contact
781-861-4467
Manufacturer Reason
for Recall		 Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothrombin time (PT) reagent, specifically HemosIL RecombiPlasTin 2G.
FDA Determined
Cause 2		 Under Investigation by firm
Action On April 8, 2022, the firm notified customers via email and certified mail. Customers were informed that the firm will stop shipment of product on May 9, 2022. After receipt of the material, customers must complete the conversion to HemosIL RecombiPlasTin 2G, with support as needed from your local Werfen representative, within 90 days. Until a lot of HemosIL RecombiPlasTin 2G has been received and ready for use, customers should run quality control for HemosIL ReadiPlasTin with each new reagent vial (every lot) and at least every 8 hours to identify vials with performance issues. Any product with failed quality control or quality control results which trend high should be discarded. Once customers have completed the comversion to HemosIL RecombiPlasTin 2G, any remaining unused HemosIL ReadiPlasTin should be destroyed.
Quantity in Commerce 1,563 (US); 29,046 (OUS)
Distribution US Nationwide distribution including in the states of AZ, CA, IA, IL, IN, KS, MD, ME, MI, MN, MO, NC, NE, NY, OH, OK, SC, TX, VA, WV.
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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