Preeclampsia growth factor assay recalled over out-of-range quality control values
B.R.A.H.M.S PlGF Plus KRYPTOR in vitro diagnostic tests are being recalled after customers observed out-of-range values at the lowest quality control level, which can contribute to falsely elevated results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a diagnostic test that can produce falsely elevated results and alter a patient's risk classification, a risk of harm with no injuries reported.
Plain-English summary
Brahms GmbH is recalling the B.R.A.H.M.S PlGF Plus KRYPTOR, catalog number 859075N, an in vitro diagnostic test for Placental Growth Factor. The action covers 5,254 units, UDI 04260157632196, lots 59172 and 859075N (both expiring 2026-11-23).
Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PlGF assay, which require troubleshooting steps to resolve. According to the manufacturer, 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 ratio may result in a higher-risk classification for progression to preeclampsia with severe features, potentially leading to intensified clinical monitoring. The FDA classified the action as Class II.
Distribution was worldwide, including the US states of North Carolina, Texas, Minnesota, Utah, New York, Florida, Ohio, Illinois, Connecticut, California and Georgia, and a number of other countries. The tests are used in clinical laboratories rather than sold to consumers.
Laboratories should follow the Instructions for Use for quality control and act on the guidance issued by the manufacturer.
The recalled product
- Product
- B¿R¿A¿H¿M¿S KRYPTOR compact REACT, REF: 89986, used with B¿R¿A¿H¿M¿S PlGF Plus KRYPTOR, REF: 859075N, and run on the B¿R¿A¿H¿M¿S KRYPTOR compact PLUS analyzers. in vitro diagnostic test for Placental Growth Factor
- Manufacturer
- Brahms GmbH
- Affected units
- 5,524
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- REF: 89986
- UDI-DI: 04260157638976
- Lots: 40102+R78
- 40102+R79
- 40102+R80. REF: 859075N
- UDI-DI: 04260157632196
- All Lots.
Distribution
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