[Recalled] Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic an
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli. |
|---|---|
| Brand / manufacturer | Siemens Healthcare Diagnostics, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0170-2015 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 17 October 2014 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 used with MicroScan Microbiology Systems.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.