Home › ELITECH MICROBIO › MYCOPLASMA CONTROL
MYCOPLASMA CONTROL
ELITECH MICROBIO · Model 00900 · UDI-DI 03661540100505
10
510(k) clearances
2
Adverse events
46
Recalls
9
Facilities
Description
The MYCOPLASMA CONTROL kit contains Ureaplasma urealyticum (U.u) and Mycoplasma hominis (M.h) strains and has been designed for the quality control of liquid media methods of in vitro urogenital mycoplasma diagnosis.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-02 | Microbiologics Inc | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. |
| 2025-12-02 | Microbiologics Inc | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. |
| 2025-12-02 | Microbiologics Inc | Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428. |
| 2025-11-13 | Microbiologics Inc | Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10. |
| 2025-06-27 | Microbiologics Inc | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted. |
| 2025-06-27 | Microbiologics Inc | KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted. |
| 2025-06-17 | Microbiologics Inc | Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the |
| 2025-05-27 | Microbiologics Inc | Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swabs; 01065K was packa |
| 2024-03-06 | Microbiologics Inc | The positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a result, users may o |
| 2023-10-18 | Microbiologics Inc | A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.