QC Sets and Panels — Class II medical device recall Z-0589-2022

Terminated recall by Microbiologics Inc, reported 2022-02-16, distributed nationwide. Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (s

Recall number	`Z-0589-2022`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Microbiologics Inc, Saint Cloud, MN, United States
Recall initiated	2020-02-18
Classified	2022-02-08
Reported by FDA	2022-02-16
Terminated	2022-07-11
Distributed	Nationwide (US)
Countries outside the US	AE, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CW, DE, DK, EC, EG, ES, FI, FR, GB, GT, HK, HR, IE, IL, IN, IT, JP, KR, KW, LB, MY, NL, NZ, PA, PE, PL, PT, QA, RO, SA, SE, SG, SV, TH, TR, TT, TW, VN, ZA
Quantity	3 units
Reason classes	specification failure
UPC / GTIN / UDI-DI	`70845357038899`
Lot numbers	`5229-01`, `5229-02`, `5229-03`, `70845357038899QC`
Model numbers	`0959P`, `5229P`

Product

QC Sets and Panels, KWIK-STIK Blood Culture Identification (BCID) Verification Panel (Live Culture). KWIK-STIK kit that contains Catalog Number 0959P. In Vitro Diagnostic Control microorganisms

Reason for recall

Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0589-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.