Recall of B.R.A.H.M.S PlGF Plus KRYPTOR Diagnostic Test

Source: FDA · Worldwide

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Brahms GmbH has voluntarily recalled 5,254 units of the B.R.A.H.M.S PlGF Plus KRYPTOR due to quality control issues that may lead to inaccurate test results for preeclampsia risk.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 22, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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Recall of B.R.A.H.M.S PlGF Plus KRYPTOR Diagnostic Test

What Happened

Brahms GmbH initiated a voluntary recall because customers observed quality control values out of range for the PIGF assay, which could result in falsely elevated sFlt-1/PlGF ratio results and potentially lead to a higher-risk classification for progression to preeclampsia with severe features.

Which Products Are Affected

The affected product is B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N, with 5,254 units impacted. The distribution includes UDI: 04260157632196 and Lot/Expiration: 59172 (2026-11-23), 859075N (2026-11-23). It was distributed to US states including NC, TX, MN, UT, NY, FL, OH, IL, CT, CA, GA, and other countries such as 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. The official recall number is Z-1795-2026.

What You Should Do

As this is a voluntary firm-initiated recall, affected parties should follow the recalling firm's instructions for troubleshooting and resolution as outlined in the product documentation.

Why This Matters

This recall affects medical diagnostic devices used for assessing preeclampsia risk, potentially leading to incorrect patient classifications and the need for intensified monitoring in healthcare settings.

Source

Attribution: FDA. For more information, refer to FDA recall event ID 98561.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Brahms GmbH has voluntarily recalled 5,254 units of the B.R.A.H.M.S PlGF Plus KRYPTOR due to quality control issues that may lead to inaccurate test results for preeclampsia risk.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.