Quick Facts at a Glance
- Recall Date
- March 12, 2026
- Hazard Level
- HIGH
- Brand
- Brahms GmbH
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Brahms GmbH
- Product type
- In Vitro Diagnostic Test
- Model numbers
- UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23)
- Sold at
- Unknown
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 12, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Brahms GmbH or your healthcare provider for instructions
About This Product
PlGF Plus KRYPTOR is an in vitro diagnostic test measuring placental growth factor for preeclampsia risk assessment. Used in clinical settings to guide patient monitoring.
Why This Is Dangerous
Out-of-range QC values at the lowest QC level may lead to underestimation during QC checks, resulting in falsely high sFlt-1/PlGF ratios and misclassification of preeclampsia risk.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Potential for incorrect patient risk stratification and inappropriate clinical decisions; immediate action required.
Practical Guidance
How to identify if yours is affected
- Check catalog number 859075N and UDI 04260157632196
- Check lot 59172 with expiration 2026-11-23 for affected units
- Verify distribution aligns with the list of US states and countries provided in recall
Where to find product info
Look up the FDA recall page Z-1795-2026 for details; contact Brahms GmbH for instructions
What timeline to expect
Refunds or replacements coordinated by Brahms GmbH; follow official guidance
If the manufacturer is unresponsive
- Escalate to regulatory authorities if the manufacturer is slow to respond
- Document all attempts to reach the company and keep records
How to prevent similar issues
- Always run QC as per Instructions for Use
- Validate QC procedures before reporting results
- Consult Brahms GmbH guidance for any anomalies
- Track lot and catalog numbers carefully for future recalls
Documentation advice
Keep recall notice, QC logs, testing results, supplier communications
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Product Details
Brand: Brahms GmbH. Product: PlGF Plus KRYPTOR. Catalog Number: 859075N. UDI: 04260157632196. Lot/Expiration: 59172(2026-11-23); 859075N(2026-11-23). Distribution: Worldwide. Recall Date: 2026-03-12. Status: ACTIVE.
Reported Incidents
No explicit injury or patient harm incidents are described in the provided data.
Key Facts
- 5,254 total units recalled
- QC Level 1 out-of-range values
- Worldwide distribution including US states NC, TX, MN, UT, NY, FL, OH, IL, CT, CA, GA
- Lot: 59172 with expiration 2026-11-23
- Catalog Number: 859075N
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