FDA Device recall Z-0582-2022
KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack
- FDA Device
- Class II
- terminated
- Published 2022-02-16
On 2022-02-16 the FDA classified a Class II recall of KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack by Microbiologics, citing potential contamination with S. epidermidis E. coli and S. warneri.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0582-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-01 |
| Published | 2022-02-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Microbiologics |
| Distribution | US |
Product
KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packaged as follows: a. KWIK-STIK(TM) 2 Pack; b. KWIK-STIK(TM) 6 Pack. Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
Reason
Potential contamination with S. epidermidis E. coli and S. warneri.
Identifiers
| code_info | a. Catalog Number: 0947P; Lot Number: 947-126-2, 947-126-4; UDI: 20845357022947. b. Catalog Number: 0947K; Lot Number: 947-126-3; UDI: 30845357022951 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0582-2022%22
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