BRAHMS KRYPTOR compact REACT, REF: 89986, used with BRAHMS… recallZ-1795-2026 · Brahms GmbH · initiated Mar 12, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Brahms GmbH or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On 2/27/2026, correction notices were sent to customers informing them: 1. Continue to perform Quality Control testing in accordance with the current Instructions for Use prior to reporting patient results. 2. If Quality Control results fall outside plus-minus 20% of target values follow the troubleshooting procedures described in the User Manual. 3. Forward this letter to those who need to be aware within your organization or to any organization to whom the potentially affected devices have been transferred. Keep this notification on file. For further questions, please contact the firm's customer service on 1-800-232-3342 or e-mail to: [email protected] On 3/12/2026, Follow-up notices were sent to customers who were informed the root cause had been identified, which identified reaction plate affected devices. Customers were asked to do the following: 1) Stop using and dispose affected reaction plates. 2) Complete and return the response form. 3) Same as point 3 above.
Recall details
- Recall number
- Z-1795-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 12, 2026
- Posted by the FDA
- Apr 8, 2026
- Recalling firm
- Brahms GmbH
- Quantity
- 5,524
- Product code
- QWH
- 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, EC, ET, ES, FR, GB, GR, HK, HU, ID, IL, IT, KW, KZ, LT, MK, ML, MX, NL, NO, PA, PL, PT, RO, RS, SE, SI, TH, TU, TW, UA, ZA
Product description
BRAHMS KRYPTOR compact REACT, REF: 89986, used with BRAHMS PlGF Plus KRYPTOR, REF: 859075N, and run on the BRAHMS KRYPTOR compact PLUS analyzers. in vitro diagnostic test for Placental Growth Factor
Code information (models, lots, serial numbers)
REF: 89986, UDI-DI: 04260157638976, Lots: 40102+R78, 40102+R79, 40102+R80. REF: 859075N, UDI-DI: 04260157632196, All Lots.
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- B.R.A.H.M.S PlGF plus KRYPTOR 859075NB.R.A.H.M.S GmbH · Prognostic Test For Development Or Progression Of Preeclampsia1 recall0 reports
- B.R.A.H.M.S KRYPTOR compact REACT 89986B.R.A.H.M.S GmbH · Fluorometer1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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