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Kit, Quality Control For Culture Media

FDA product code JTR · Class 1 · Microbiology

1,641
Registered devices
2
Adverse events
46
Recalls
12
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-12-02Microbiologics IncAffected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
2025-12-02Microbiologics IncAffected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
2025-12-02Microbiologics IncAffected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
2025-11-13Microbiologics IncSome products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
2025-06-27Microbiologics IncKWIK-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.
2025-06-27Microbiologics IncKWIK-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.
2025-06-17Microbiologics IncAffected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delay
2025-05-27Microbiologics IncAffected products were packaged with the incorrect KWIK STIK assembly resulting in the product containing the wrong microorganism. 0621K was packaged 01065K swa
2024-03-06Microbiologics IncThe positive control material (Rhizopus stolonifer) within the KWIK-STIK assembly was contaminated with another fungal organism (Aspergillus brasiliensis). As a
2023-10-18Microbiologics IncA complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.

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