Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported April 21, 2021
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
Possible false negative or false positive results due to the product being compromised during shipment.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries Inc recalled Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site t… - a moderate-severity action.
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site t… was recalled by Medline Industries Inc in April 21, 2021. Reason: Possible false negative or false positive results due to the product being compromised during shipment.. Check the official notice for the remedy. Verify recall #Z-1407-2021 with the FDA Devices before acting.
The recall
Medline Industries Inc issued this moderate-severity FDA Devices recall-Possible false negative or false positive results due to the product being compromised during shipment..
- Moderate
- severity level
- 24 units
- affected scope
- Class II
- classification
- April 21, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1407-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1407-2021) was formally reported on April 21, 2021, with the manufacturer initiating the action on March 15, 2021. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medline Industries Inc is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 24 each.
The documented reason for this recall is: Possible false negative or false positive results due to the product being compromised during shipment. Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of Ohio.. 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
24 each
Related Recalls
6
3 from same agency
Product description
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.
Reason for recall
Possible false negative or false positive results due to the product being compromised during shipment.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1407-2021 |
| Date reported | April 21, 2021 |
| Date initiated | March 15, 2021 |
| Recalling firm | Medline Industries Inc |
| Firm location | Northfield, IL |
| Affected scope | 24 each |
| Distribution | US Nationwide distribution in the state of Ohio. |
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-1407-2021) 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? ▼
Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test cards to dilute specimens containing high levelsof B-hydroxybutrate into the test range.. Recalled by Medline Industries Inc. Units affected: 24 each.
Why was this product recalled? ▼
Possible false negative or false positive results due to the product being compromised during shipment.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1407-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the state of Ohio..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1407-2021) 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.
Nearby Recalls in This Category
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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 April 21, 2021. 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.