Recall Z-0636-2022
Microbiologics Inc · initiated March 2, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.
Codes / lots: Catalog Number: 0939P, Lot Number: 939-47-2, UDI: 20845357022701
Reason for recall
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
FDA-determined cause: Labeling False and Misleading
Action taken
Microbiologics notified customers on about 03/02/2017, via letter titled "Medical Device Recall." Customers were instructed to: 1. DO NOT USE any lot number 939-47-1 or 939-47-2 you may have in inventory. 2. QUARANTINE or DISCARD the product to prevent further use. 3. RETURN any remaining inventory you have of this product to Microbiologics via FED-EX though the use of FED-EX account number 355830926, and mark box Attention: Technical Manager. 4. Acknowledge your receipt of this information by completing the attached form and returning to Microbiologics by e-mailing to tsobania@microbiolgics.com or by faxing to 320.253.6250.
Details
- Recall number
- Z-0636-2022
- Initiated
- March 2, 2017
- Terminated
- April 22, 2022
- Product code
- JTR – Kit, Quality Control For Culture Media
- Quantity
- 2 units
- Distribution
- International distribution in the countries of Canada and Germany.
- Recalling firm
- Microbiologics Inc, Saint Cloud, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0637-2022 Class III | LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit…Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. | 03/02/2017Terminated |