CLASS II Device recall · Reported 4 Nov 2020 · FDA Enforcement Report
Each Kwik-stik unit contains a lyophilized microorganism recalled
Microbiologics is recalling Each Kwik-stik unit contains a lyophilized microorganism pellet, an ampoule of hydrating. The recall was initiated on 8 Oct 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0304-2021
- FDA event ID
- 86576
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Oct 2020
- FDA classified
- 27 Oct 2020
- Reported
- 4 Nov 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 8 Oct 2020 | Recall initiated by company | |
| 27 Oct 2020 | Classified by FDA | +19 days |
| 4 Nov 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.
Questions about this recall
Is Each Kwik-stik unit contains a lyophilized microorganism pellet, an ampoule of hydrating recalled?
Yes. Microbiologics recalled Each Kwik-stik unit contains a lyophilized microorganism pellet, an ampoule of hydrating on 8 Oct 2020. The recall is Class II and its status is Terminated. Recall number Z-0304-2021.
Why was it recalled?
QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
Which lots are affected?
Catalog 5226P, Lots 5226-03, 5226-04, 5226-05, 5226-06, 5226-07 UDI: 70845357037335
Where was it sold?
Distribution in US, Brazil, Canada, Costa Rica, France, Germany, Ireland, Italy, Japan, New Zealand, Sweden, and United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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