Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported November 19, 2014
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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Siemens Healthcare Diagnostics, Inc. recalled Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are… - a critical-severity action.
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are… was recalled by Siemens Healthcare Diagnostics, Inc. in November 19, 2014. Reason: An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Comb…. Check the official notice for the remedy. Verify recall #Z-0170-2015 with the FDA Devices before acting.
The recall
Siemens Healthcare Diagnostics, Inc. issued this critical-severity FDA Devices recall-An increase in false positive susceptible results on Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Comb….
- Critical
- severity level
- 1K units
- affected scope
- Class I
- classification
- November 19, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0170-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0170-2015) was formally reported on November 19, 2014, with the manufacturer initiating the action on October 17, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Siemens Healthcare Diagnostics, Inc. is listed as the recalling firm, operating out of West Sacramento, CA. Federal records list the affected scope as 1381.
The documented reason for this recall 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. Distribution data in the federal record shows the product reached: Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada.. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1381
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0170-2015 |
| Date reported | November 19, 2014 |
| Date initiated | October 17, 2014 |
| Recalling firm | Siemens Healthcare Diagnostics, Inc. |
| Firm location | West Sacramento, CA |
| Affected scope | 1381 |
| Distribution | Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada. |
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-0170-2015) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 1381.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2014. Severity: Critical. Recall number: Z-0170-2015.
Where was the recalled product distributed? ▼
Distribution: Distributed US (nationwide) including the states of IA, CA, NY, WI, MI, SD, NC, FL, HI, OH, WA, TX, WA, IN, NM, MS, KY, IL, UT, ND, and WY and the country of Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0170-2015) 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 19, 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.