Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400 recallZ-0895-2018 · Instrumentation Laboratory Co. · initiated Aug 2, 2017
Class II Terminated All recalls posted in March 2018
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 Co. 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
Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample results.
FDA root cause category: Under Investigation by firm
What the company is doing
On August 2, 2017, Instrumentation Laboratory sent an Urgent Medical Device Removal letters dated August 2, 2017 to their customers. On October 5, 2017 Instrumentation Laboratory expanded their recall adding 3 additional lots to a second Urgent Medical Device Removal letter. On February 26, 2018, Instrumentation Laboratory expanded their recall a 3rd time to include 1 additional lot to a third Urgent Medical Device Removal letter. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete a Mandatory Tracking Response form. For questions contact your Customer Service Representative at 1-800-955-9525, option #1.
Recall details
- Recall number
- Z-0895-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 2, 2017
- Posted by the FDA
- Mar 3, 2018
- Recalling firm
- Instrumentation Laboratory Co.
- Quantity
- 14,894 kits
- Product code
- GJS
- FDA submissions
- K122584
- Distribution
- Worldwide Distribution - US Nationwide
Product description
Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
Code information (models, lots, serial numbers)
Lots: N1166235, N0177760, N0278358, N0478057, N0479504 & N0278177.
Other devices under the same FDA submission
1 device cleared under K122584 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- 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 18, 2026. Text above is shown as published by the FDA.
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