Key facts
| Recalling firm | Brahms GmbH |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor |
| Classification | Class II |
| Recall number | Z-1795-2026 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| 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. |
What this classification means
FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Brahms GmbH and the affected product is described in FDA's record as: B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor. FDA's stated reason for the recall is: 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 (additional items listed in FDA's full record). The recall is tracked under FDA recall number Z-1795-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
What consumers should do
Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor -- and the recall number Z-1795-2026. If it matches, stop using or distributing it and contact Brahms GmbH or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.
Brahms GmbH’s FDA history
Argus HQ has recorded 1 total FDA action tied to Brahms GmbH: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
- Where can I verify this recall directly with FDA?
- The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
- What was recalled and why?
- Brahms GmbH recalled B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor. FDA's record states the reason for recall as: 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 (additional items listed in FDA's full record). The.
- How serious is this recall?
- FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
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Related enforcement actions
Full FDA history for Brahms GmbHCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2026). FDA Recall Database: Class II Recall: B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in… by Brahms GmbH. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/fda-recall-brahms-gmbh-z-1795-2026
"FDA Recall Database: Class II Recall: B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in… by Brahms GmbH." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/recall/fda-recall-brahms-gmbh-z-1795-2026.
Argus HQ Research. "FDA Recall Database: Class II Recall: B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in… by Brahms GmbH." Digital Empire Holdings LLC. Accessed August 29, 2026. https://argushq.ai/recall/fda-recall-brahms-gmbh-z-1795-2026.
@misc{argushq_argushq_ai_recall_fda_recall_brahms_gmbh_z_1795_2026_2026,
title = {FDA Recall Database: Class II Recall: B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in… by Brahms GmbH},
author = {{Argus HQ Research}},
year = {2026},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/fda-recall-brahms-gmbh-z-1795-2026},
note = {Accessed: August 29, 2026}
}Source: FDA.gov — Recalls ↗