Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported January 8, 2014
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
Kits incompatible with certain fluorescence microscope light sources
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
AdvanDx, Inc. recalled AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enter… - a low-severity action.
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enter… was recalled by AdvanDx, Inc. in January 8, 2014. Reason: Kits incompatible with certain fluorescence microscope light sources. Check the official notice for the remedy. Verify recall #Z-0619-2014 with the FDA Devices before acting.
The recall
AdvanDx, Inc. issued this low-severity FDA Devices recall-Kits incompatible with certain fluorescence microscope light sources.
- Low
- severity level
- Class III
- classification
- January 8, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0619-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0619-2014) was formally reported on January 8, 2014, with the manufacturer initiating the action on December 11, 2013. It is classified under Low severity (Class III), with a current status of Terminated. AdvanDx, Inc. is listed as the recalling firm, operating out of Woburn, MA. Federal records list the affected scope as 49 kits US; 17 kits OUS.
The documented reason for this recall is: Kits incompatible with certain fluorescence microscope light sources Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark.. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
49 kits US; 17 kits OUS
Related Recalls
6
3 from same agency
Product description
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures
Reason for recall
Kits incompatible with certain fluorescence microscope light sources
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0619-2014 |
| Date reported | January 8, 2014 |
| Date initiated | December 11, 2013 |
| Recalling firm | AdvanDx, Inc. |
| Firm location | Woburn, MA |
| Affected scope | 49 kits US; 17 kits OUS |
| Distribution | Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark. |
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-0619-2014) 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? ▼
AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures. Recalled by AdvanDx, Inc.. Units affected: 49 kits US; 17 kits OUS.
Why was this product recalled? ▼
Kits incompatible with certain fluorescence microscope light sources
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2014. Severity: Low. Recall number: Z-0619-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including CA, IL, IN, OH, NJ, MI , MO, NY, WI. Internationally to Denmark..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0619-2014) 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 January 8, 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.