Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 23, 2015
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
MedtestDx, Inc. recalled MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml am… - a moderate-severity action.
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml am… was recalled by MedtestDx, Inc. in September 23, 2015. Reason: Vial to vial variation in the fill volume that could affect control recovery issues and cause a control resul…. Check the official notice for the remedy. Verify recall #Z-2768-2015 with the FDA Devices before acting.
The recall
MedtestDx, Inc. issued this moderate-severity FDA Devices recall-Vial to vial variation in the fill volume that could affect control recovery issues and cause a control resul….
- Moderate
- severity level
- Class II
- classification
- September 23, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2768-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2768-2015) was formally reported on September 23, 2015, with the manufacturer initiating the action on May 15, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. MedtestDx, Inc. is listed as the recalling firm, operating out of Canton, MI. Federal records list the affected scope as 79 kits.
The documented reason for this recall is: Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 … Distribution data in the federal record shows the product reached: US Nationwide Distribution.. 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
79 kits
Related Recalls
6
3 from same agency
Product description
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.
Reason for recall
Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2768-2015 |
| Date reported | September 23, 2015 |
| Date initiated | May 15, 2015 |
| Recalling firm | MedtestDx, Inc. |
| Firm location | Canton, MI |
| Affected scope | 79 kits |
| Distribution | US Nationwide Distribution. |
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-2768-2015) 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? ▼
MedTest DX Control Reconstitution Fluid Kit configuration: 20 x 5 ml. Bottle: 5 ml amber glass Cap: 18 mm white seal plug seal rubber HC-DIL (Human Control Diluent) is reagent grade water filled into 5ml vials used to reconstitute Human controls HNC200 and HEC200. in vitro diagnostic.. Recalled by MedtestDx, Inc.. Units affected: 79 kits.
Why was this product recalled? ▼
Vial to vial variation in the fill volume that could affect control recovery issues and cause a control result to fall outside the suggested recovery ranges. An under-fill of the vials was found ranging as low as 4.63 ml. When used to reconstitute HNC/HEC, control values were shown to be out of range running on the high end.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2015. Severity: Moderate. Recall number: Z-2768-2015.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2768-2015) 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 September 23, 2015. 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.