Hemochron Jr. Whole Blood Microcoagulation System APTT… recallZ-2088-2014 · ITC-Nexus Dx · initiated Jun 20, 2014
Class II Terminated All recalls posted in July 2014
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 ITC-Nexus Dx 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
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
FDA root cause category: Device Design
What the company is doing
ITC issued an Urgent Medical Device Recall Letters/Response Forms dated June 20, 2014, to End-users and US Distributors were notified. ITC asks that this communication be forwarded to all those within your organization who need to be aware of this matter. If any affected products have been forwarded to another facility, a copy of this communication should be forwarded to them immediately. Customers should check their inventory for the affected lot. The affected lot should not be used and quarantined until return to ITC. The attached form should be completed and returned to ITC within 10 days. ITC will review the form and contact the customer to coordinate any returns. For questions, please contact Technical Support: Telephone 732-548-5700, Extension 4011 E-mail: [email protected] Normal business hours are Monday through Friday, 8:00 AM to 6:30 PM, Eastern Time.For urgent matters, Technical Support is available 24 hours per day, 7 days a week.
Recall details
- Recall number
- Z-2088-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 20, 2014
- Posted by the FDA
- Jul 21, 2014
- Recalling firm
- ITC-Nexus Dx
- Quantity
- US- 315 cuvettes; OUS - 2835 cuvettes
- Product code
- JPA
- FDA submissions
- K940401
- Distribution
- Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.
Product description
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Code information (models, lots, serial numbers)
Lot Number A4JCA001
Other devices under the same FDA submission
1 device cleared under K940401 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Hemochron Whole Blood Microcoagulation System J103Accriva Diagnostics Holdings, Inc. · System, Multipurpose For In Vitro Coagulation Studies1 report
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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