B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
Summary
The FDA issued a Class II for B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic tes by Brahms GmbH. Reason: Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubles.
Details
Source
Device Recall
External ID
Z-1795-2026
Action Date
2026-04-15
Status
Ongoing
Category
device
Product Description
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
Lot/Code Info: UDI: 04260157632196. Lot(Expiration): 59172(2026-11-23), 859075N(2026-11-23)
Quantity Affected: 5,254
Reason for Recall
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.
Distribution
Worldwide distribution. US states: NC, TX, MN, UT, NY, FL, OH, IL, CT, CA, GA. Other countries: DE, AT, AL, AU, BG, BR, CA, CH, CZ, DK, ET, ES, FR, GB, GR, HK, HU, ID, IL, IT, KW, KZ, LT, MK, ML, MX, NL, NO, PA, PL, PT, RO, SE, SI, TH, TU, TW, UA, ZA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-12
Company
Hennigsdorf
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 232 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Brahms GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Brahms GmbH have FDA actions?
This is the only FDA action we have on record for Brahms GmbH in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1795-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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