Severity
Critical
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.
Reported: January 25, 2017 Initiated: November 23, 2016 #Z-0976-2017 3723 units in total units
BioMerieux SA issued this FDA Devices recall on January 25, 2017. Classified as Critical severity (Class I). Approximately 3723 units in total units are affected. The recall was issued because: A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0976-2017) was formally reported on January 25, 2017, with the manufacturer initiating the action on November 23, 2016. It is classified under Critical severity (Class I), with a current status of Terminated. BioMerieux SA is listed as the recalling firm, operating out of Marcy L'Etoile. Federal records indicate 3723 units in total units are affected.
The documented reason for this recall is: A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016. Distribution data in the federal record shows the product reached: Worldwide distribution. US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, Greece, China, Hun…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
3723 units in total
Related Recalls
6
6 from same agency
Product Description
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.
Reason for Recall
A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.
Details
- Recalling Firm
- BioMerieux SA
- Units Affected
- 3723 units in total
- Distribution
- Worldwide distribution. US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, Greece, China, Hungary, India, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Russia Fed., Sweden, Singapore, Thailand, Turkey, South Africa; Distributors in: Peru, Kenya, Morocco, Serbia, Romania, Uruguay, Latvia, Dutch Antilles, Israel, Georgia, Armenia, Malaysia, Belarus and Direct Customers in: Togo, Djibouti, Burkina Faso, Mongolia, Zimbabwe, Uganda and Iraq.
- Location
- Marcy L'Etoile
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0976-2017 |
| Date reported | January 25, 2017 |
| Date initiated | November 23, 2016 |
| Recalling firm | BioMerieux SA |
| Units affected | 3723 units in total |
| Distribution | Worldwide distribution. US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, Greece, China, Hungary, India, Italy, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
MagSIL (NucliSENS easyMAG Magnetic Silica), Product Usage: The NucliSENS¿ easyMAG¿ system is an in vitro diagnostic medical device and is intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens.. Recalled by BioMerieux SA. Units affected: 3723 units in total.
Why was this product recalled? ▼
A drift of the performance with the BK test (BK virus, worst case application) was observed for some silica batches of Magnetic Silica (MagSil). This is the same issue as in recall Z-2342-2016.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2017. Severity: Critical. Recall number: Z-0976-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US Nationwide; BioMerieux Subsidiaries in: Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech republic, Germany, Spain, France United Kingdom, Greece, China, Hungary, India, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Russia Fed., Sweden, Singapore, Thailand, Turkey, South Africa; Distributors in: Peru, Kenya, Morocco, Serbia, Romania, Uruguay, Latvia, Dutch Antilles, Israel, Georgia, Armenia, Malaysia, Belarus and Direct Customers in: Togo, Djibouti, Burkina Faso, Mongolia, Zimbabwe, Uganda and Iraq..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0976-2017) 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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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
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All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).