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Terminated

KWIK-STIK, Candida parapsilosis derived from ATCC 22019, REF 0726P. Packaged 2 units per pack. IVD controls.

FDA Recall Z-0543-2022 · Posted 2022-01-28

Recalling FirmMicrobiologics Inc
Recall StatusTerminated
Product CodeJTR
Date Initiated2021-02-24
Date Terminated2022-07-11
Product Quantity65 packs (130 units)

Reason for Recall

Potential that products packaged for lot 726-57-10 were packaged in pouches labeled as 323-108-7.

Firm Action

Microbiologics notified customers on about 02/24/2021 via letter titled "Urgent Medical Device Recall." Instructions included to inspect inventory for affected products. If found, instructions were to: 1. REVIEW lab procedures to understand how this information affects your usage; 2. USE OR DISCARD depending on your lab procedures and how this information affects your usage; 3. COMPLETE the response form provided; 4. RETURN the response form to [email protected]; 5. KEEP this letter for your records; 6. CONTACT Microbiologics if a replacement kit is needed. Questions or concerns can be directed to Recall Support team at 320.229.7073 or [email protected].

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide distribution - US distribution in the states of GA, MS, MT, NC, NM, NV, TN, TX, WA, WI and the countries of Brazil, Canada, China, Colombia, Dominican Republic, France, India, Ireland, Japan, Mexico, Oman, Philippines, Romania, South Africa, Turkey, United Arab Emirates.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K861022KWIK STIK(TM) LYFO(TM) DISK MICROORGANISMSMicro-Bio-Logics · 1986-04-04

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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