BD Kiestra B.V.
Drachten Fryslan, NL
BD Kiestra B.V. appears in FDA device records in Drachten Fryslan, NL. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to BD Kiestra B.V. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- BD KIESTRA LAB AUTOMATIONenforcement report, recall
510(k) clearance history
FDA records hold 1 510(k) clearance for BD Kiestra B.V. in 2023.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010141591 | 3010141591 | BD Kiestra B.V. | Marconilaan 6, Drachten Fryslan 9207 JC NL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KZBAutomated Colony Counter
- QQVAutomated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry
- JTQBath, Incubators/Water, All
- JQPCalculator/Data Processing Module, For Clinical Use
- QQYCulture Plate Imaging System For Qualitative Assessment Of Resistant Organisms
- LIBDevice, General Purpose, Microbiology, Diagnostic
- JTCDevice, Microtiter Diluting/Dispensing
- LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1658-2026 | BD Kiestra" ReadA; Catalog No.: 446948. | In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity. | Class II | Open, Classified |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets BD Kiestra B.V. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain