Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 14, 2018
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of
An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occu…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Qiagen Sciences LLC recalled EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 A… - a moderate-severity action.
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 A… was recalled by Qiagen Sciences LLC in November 14, 2018. Reason: An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to tri…. Check the official notice for the remedy. Verify recall #Z-0383-2019 with the FDA Devices before acting.
The recall
Qiagen Sciences LLC issued this moderate-severity FDA Devices recall-An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to tri….
- Moderate
- severity level
- 298 units
- affected scope
- Class II
- classification
- November 14, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0383-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0383-2019) was formally reported on November 14, 2018, with the manufacturer initiating the action on July 23, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Qiagen Sciences LLC is listed as the recalling firm, operating out of Germantown, MD. Federal records list the affected scope as 298.
The documented reason for this recall is: An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be com… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, GA, IA, ID, IL, MA, MD, MI, MN, NE, NJ, NY, NV, OH, PA, PR, SD, VA, and WA. The products were distributed to the following foreign countries: Alg…. 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
298
Related Recalls
6
3 from same agency
Product description
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ1 Advanced XL.
Reason for recall
An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be compromised and extractions need to be repeated. This could cause a delay in obtaining results from downstream applications.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0383-2019 |
| Date reported | November 14, 2018 |
| Date initiated | July 23, 2018 |
| Recalling firm | Qiagen Sciences LLC |
| Firm location | Germantown, MD |
| Affected scope | 298 |
| Distribution | Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, GA, IA, ID, IL, MA, MD, MI, MN, NE, NJ, NY, NV, OH, PA, PR, SD, VA, and WA. The products were distributed to the following foreign countries: Alger, Argentina, Austr… |
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-0383-2019) 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? ▼
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ1 Advanced XL.. Recalled by Qiagen Sciences LLC. Units affected: 298.
Why was this product recalled? ▼
An issue with the power branching printed circuit board (PCB) on the instrument that has the potential to trigger a heater malfunction was discovered. If this failure were to occur, nucleic acid extractions could be compromised and extractions need to be repeated. This could cause a delay in obtaining results from downstream applications.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 14, 2018. Severity: Moderate. Recall number: Z-0383-2019.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the states of: AZ, CA, FL, GA, IA, ID, IL, MA, MD, MI, MN, NE, NJ, NY, NV, OH, PA, PR, SD, VA, and WA. The products were distributed to the following foreign countries: Alger, Argentina, Australia, Austria, Canada, China, Dubai, Egypt, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Korea, Latvia, Mexico, Morocco, Norway, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Tunisia, Turkey, UK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0383-2019) 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 November 14, 2018. 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.