FDA Device recall Z-0714-2022
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
- FDA Device
- Class II
- terminated
- Published 2022-03-09
On 2022-03-09 the FDA classified a Class II recall of KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299 by Microbiologics, citing this strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house tes….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0714-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-06 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (single-pack) Enterococcus faecalis derived from ATCC 51299
Reason
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Identifiers
| code_info | Catalog Number HL163263 OEM Private Label with Healthlink; UDI: N/A (OEM agreement with Healthlink ended in Q1 2016 b…Catalog Number HL163263 OEM Private Label with Healthlink; UDI: N/A (OEM agreement with Healthlink ended in Q1 2016 before UDI was required for class 1 IVDs) Lot Number (Expiration Date): 959-74-1 (10/08/2014), 959-75-2 (04/22/2015), 959-75-3 (04/22/2015), 959-75-6 (04/22/2015), 959-75-7 (04/22/2015), 959-75-10 (04/22/2015), and 959-76-2 (07/08/2015) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Microbiologics
- KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
FDA Device · Class II · 2025-12-31 · Microbiologics - LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
FDA Device · Class II · 2025-12-31 · Microbiologics - KWIK-STIK 2-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325P
FDA Device · Class II · 2025-12-31 · Microbiologics - KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
FDA Device · Class II · 2025-12-10 · Microbiologics - LYFO-DISK, M. Canis Derived from ATCC 36299, packaged as: 1) REF 0894K (6-pack), 2) REF 0894P (2-pack)
FDA Device · Class II · 2025-08-06 · Microbiologics
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0714-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.