Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 1, 2016
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
Accriva Diagnostics Inc., dba Itc, dba Accumetrics recalled Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA0… - a moderate-severity action.
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA0… was recalled by Accriva Diagnostics Inc., dba Itc, dba Accumetrics in June 1, 2016. Reason: Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to e…. Check the official notice for the remedy. Verify recall #Z-1720-2016 with the FDA Devices before acting.
The recall
Accriva Diagnostics Inc., dba Itc, dba Accumetrics issued this moderate-severity FDA Devices recall-Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to e….
- Moderate
- severity level
- Class II
- classification
- June 1, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1720-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1720-2016) was formally reported on June 1, 2016, with the manufacturer initiating the action on April 22, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Accriva Diagnostics Inc., dba Itc, dba Accumetrics is listed as the recalling firm, operating out of San Diego, CA. Federal records list the affected scope as 135 boxes.
The documented reason for this recall is: Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result. Distribution data in the federal record shows the product reached: U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany.. 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
135 boxes
Related Recalls
6
3 from same agency
Product description
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.
Reason for recall
Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1720-2016 |
| Date reported | June 1, 2016 |
| Date initiated | April 22, 2016 |
| Recalling firm | Accriva Diagnostics Inc., dba Itc, dba Accumetrics |
| Firm location | San Diego, CA |
| Affected scope | 135 boxes |
| Distribution | U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany. |
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-1720-2016) 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? ▼
Accriva- APTT Cuvette for use on the Hemochron Jr. test system, catalog #J103, lot B6JCA012.. Recalled by Accriva Diagnostics Inc., dba Itc, dba Accumetrics. Units affected: 135 boxes.
Why was this product recalled? ▼
Clot activating reagent mis-positioned or visibly absent in the cuvette's test channel causing APTT test to either have an error code or an erroneously high result.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 1, 2016. Severity: Moderate. Recall number: Z-1720-2016.
Where was the recalled product distributed? ▼
Distribution: U.S. distribution to the following; state: VA. Foreign distribution to the following; China, Italy, Germany..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1720-2016) 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 June 1, 2016. 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.