Microbiologics Inc recalls KWIK-STIK
Reason for recall
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Lot / code information
- UDI
- 30845357020018
- Lot #
- 818-111-7
What the firm is doing
An Urgent Medical Device Recall notification letter dated 11/13/25 was sent to customers. INSTRUCTIONS: 1.CONTACT END USERS who have received or may have received the affected items above and provide them with the Customer Communication and Customer Response Forms. 2.COMPLETE the Distributor Response Form provided. 3.RETURN the response forms to recall@microbiologics.com. 4.KEEP this letter for your records. 5.CONTACT Microbiologics if a replacement kit is needed. Microbiologics is dedicated to ensuring the success of your quality control processes. Please contact our Recall Support team at 320.229.7080 or recall@microbiologics.com with questions or concerns. Collect calls may be made.
DistributionShow detailsHide
International distribution to the countries of UAE, China, Singapore, Kazakhstan,
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0876-2026
- FDA device classification · JTROfficial FDA classification for this device type
- CFR regulation · 21 CFR 866.2480The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Microbiologics IncSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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