Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Microbiologics with 66 device recalls and 18 510(k) clearances. The most recent is a device recall dated Dec 2, 2025: KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Nu….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Dec 2, 2025 | KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325PClass II · Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. | Device recalls |
| Dec 2, 2025 | KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325KClass II · Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. | Device recalls |
| Dec 2, 2025 | LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325LClass II · Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. | Device recalls |
| Nov 13, 2025 | KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818KClass II · Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. | Device recalls |
| Jun 27, 2025 | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)Class II · KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All | Device recalls |
| Jun 27, 2025 | LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894LClass II · KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All | Device recalls |
| Jun 17, 2025 | KWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805LClass II · Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the | Device recalls |
| May 27, 2025 | KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, StaphClass II · Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong micr | Device recalls |
| Oct 7, 2019 | Cepheid Xpert Respiratory Control PanelK190086 · PMN | 510(k) clearances |
| Jun 25, 2019 | Cepheid Xpert SA Nasal Complete Control PanelK191168 · PMN | 510(k) clearances |
| Jun 20, 2019 | Cepheid Xpert MRSA NxG Control PanelK191172 · PMN | 510(k) clearances |
| May 8, 2019 | Cepheid Xpert CT/NG Control PanelK190223 · PMN | 510(k) clearances |
| Apr 19, 2019 | Cepheid Xpert C. difficile/Epi Control PanelK190463 · PMN | 510(k) clearances |
| Nov 8, 2018 | Cepheid Xpert GBS LB Control PanelK182472 · PMN | 510(k) clearances |
| Aug 28, 2018 | BD MAX CT/GC/TV 20-Day QC PanelK181683 · PMN | 510(k) clearances |
| Aug 15, 2018 | BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC PanelK181711 · PMN | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
