HemosIL ReadiPlasTin, Part No. 0020301400 recallZ-1052-2022 · Instrumentation Laboratory · initiated Apr 8, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Instrumentation Laboratory or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-1052-2022
- Status
- Open, Classified
- Initiated by the company
- Apr 8, 2022
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 1,563 (US); 29,046 (OUS)
- Product code
- GJS
- FDA submissions
- K122584
- 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.
Product description
HemosIL ReadiPlasTin, Part No. 0020301400
Code information (models, lots, serial numbers)
UDI 08426950632887 All in-date lots are affected by this recall.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HemosIL ReadiPlasTin (20 mL) 00020301400Instrumentation Laboratory Company · TEST, TIME, PROTHROMBIN2 recalls2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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