Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 30, 2014
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
ITC-Nexus Dx recalled Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic c… - a moderate-severity action.
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic c… was recalled by ITC-Nexus Dx in July 30, 2014. Reason: Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized…. Check the official notice for the remedy. Verify recall #Z-2088-2014 with the FDA Devices before acting.
The recall
ITC-Nexus Dx issued this moderate-severity FDA Devices recall-Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized….
- Moderate
- severity level
- Class II
- classification
- July 30, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2088-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2088-2014) was formally reported on July 30, 2014, with the manufacturer initiating the action on June 20, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. ITC-Nexus Dx is listed as the recalling firm, operating out of Edison, NJ. Federal records list the affected scope as US- 315 cuvettes; OUS - 2835 cuvettes.
The documented reason for this recall is: Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples. Distribution data in the federal record shows the product reached: Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
US- 315 cuvettes; OUS - 2835 cuvettes
Related Recalls
6
3 from same agency
Product description
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Reason for recall
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2088-2014 |
| Date reported | July 30, 2014 |
| Date initiated | June 20, 2014 |
| Recalling firm | ITC-Nexus Dx |
| Firm location | Edison, NJ |
| Affected scope | US- 315 cuvettes; OUS - 2835 cuvettes |
| Distribution | Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2088-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.. Recalled by ITC-Nexus Dx. Units affected: US- 315 cuvettes; OUS - 2835 cuvettes.
Why was this product recalled? ▼
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2014. Severity: Moderate. Recall number: Z-2088-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US including the states of Georgia, Virginia and New York., and the countries of Canada, France, Italy, Liechtenstein and Romania..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2088-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 30, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.