Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 25, 2017
Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.
Great Basin Scientific, Inc. recalled Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Pa… — a moderate-severity action.
Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Pa… was recalled by Great Basin Scientific, Inc. in January 25, 2017. Reason: The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a …. Check the official notice for the remedy. Verify recall #Z-1051-2017 with the FDA Devices before acting.
The recall
Great Basin Scientific, Inc. issued this moderate-severity FDA Devices recall — The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a ….
- Moderate
- severity level
- Class II
- classification
- January 25, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1051-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1051-2017) was formally reported on January 25, 2017, with the manufacturer initiating the action on December 12, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Great Basin Scientific, Inc. is listed as the recalling firm, operating out of Salt Lake City, UT. Federal records list the affected scope as 32 Kits (320 individual disposable cartridges).
The documented reason for this recall is: The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive. 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, 6 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 — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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
32 Kits (320 individual disposable cartridges)
Related Recalls
6
6 from same agency
Product description
Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.
Reason for recall
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1051-2017 |
| Date reported | January 25, 2017 |
| Date initiated | December 12, 2016 |
| Recalling firm | Great Basin Scientific, Inc. |
| Firm location | Salt Lake City, UT |
| Affected scope | 32 Kits (320 individual disposable cartridges) |
| 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-1051-2017) 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? ▼
Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.. Recalled by Great Basin Scientific, Inc.. Units affected: 32 Kits (320 individual disposable cartridges).
Why was this product recalled? ▼
The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 25, 2017. Severity: Moderate. Recall number: Z-1051-2017.
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-1051-2017) 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
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported January 25, 2017.
- 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)
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.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. 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 June 2026.