Recall of B.R.A.H.M.S PlGF Plus KRYPTOR Diagnostic Test
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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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
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 ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,456 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 22, 2026.
Frequently Asked Questions
Common questions about this FDA recall.