PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported May 15, 2013

Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.

Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan …

Recall #
Z-1272-2013
Affected scope
21,608 boxes = 432,160 panels
Initiated
March 6, 2013
Verify with FDA Devices →
View my saved recalls

Siemens Healthcare Diagnostics, Inc. recalled Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. … — a moderate-severity action.

Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. … was recalled by Siemens Healthcare Diagnostics, Inc. in May 15, 2013. Reason: Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads wi…. Check the official notice for the remedy. Verify recall #Z-1272-2013 with the FDA Devices before acting.

The recall

Siemens Healthcare Diagnostics, Inc. issued this moderate-severity FDA Devices recall — Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads wi….

Moderate
severity level
Class II
classification
May 15, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1272-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1272-2013) was formally reported on May 15, 2013, with the manufacturer initiating the action on March 6, 2013. It is classified under Moderate severity (Class II), 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 21,608 boxes = 432,160 panels.

The documented reason for this recall is: Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems. Distribution data in the federal record shows the product reached: US Nationwide Distribution including Puerto Rico.. 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

-1,00001,0002,0003,0004,0005,000 20052008201120142017202020232026 1,243

Where this recall sits in the database

Severity2366872097High severity (most serious)Moderate severityLow severity
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.

Severity

Moderate

Affected scope

21,608 boxes = 432,160 panels

Related Recalls

6

6 from same agency

Product description

Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.

Reason for recall

Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1272-2013
Date reported May 15, 2013
Date initiated March 6, 2013
Recalling firm Siemens Healthcare Diagnostics, Inc.
Firm location West Sacramento, CA
Affected scope 21,608 boxes = 432,160 panels
Distribution US Nationwide Distribution including Puerto Rico.

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-1272-2013) 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?
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 21,608 boxes = 432,160 panels.
Why was this product recalled?
Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 15, 2013. Severity: Moderate. Recall number: Z-1272-2013.
Where was the recalled product distributed?
Distribution: US Nationwide Distribution including Puerto Rico..
How do I check if my product is affected by a recall?
Check the product description and recall number (Z-1272-2013) 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.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with GE HealthCare TRADE IN CARESCAPE TELEMETRY SERVER ARK-2250L… →

Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 15, 2013.

  • 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.