HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An… recallZ-0276-2022 · Instrumentation Laboratory · initiated Oct 13, 2021
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
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0276-2022
- Status
- Open, Classified
- Initiated by the company
- Oct 13, 2021
- Posted by the FDA
- Nov 23, 2021
- Recalling firm
- Instrumentation Laboratory
- Quantity
- 5828 kits (310 US)
- Product code
- GJS
- FDA submissions
- K122584
- 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.
Product description
HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
Code information (models, lots, serial numbers)
Lot N0705526 UDI: 08426950632887 ***Updated 3/3/22*** Firm has expanded recall to include the following lot: N0806224
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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