| Class 2 Device Recall HemosIL ReadiPlasTin | |
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
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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
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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.
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Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GJS
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