CLASS II Device recall · Reported 9 Mar 2022 · FDA Enforcement Report
QC Sets and Panels: Kwik-stik Cepheid Smart GBS QC Set recalled
Microbiologics is recalling QC Sets and Panels: Kwik-stik Cepheid Smart GBS QC Set (Live Culture), distributed nationwide in the US. The recall was initiated on 1 Dec 2015 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-0704-2022
- FDA event ID
- 89517
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Dec 2015
- FDA classified
- 1 Mar 2022
- Reported
- 9 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 1 Dec 2015 | Recall initiated by company | |
| 1 Mar 2022 | Classified by FDA | +2282 days |
| 9 Mar 2022 | 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
The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the quality control test causes a disruption for the testing laboratory which may result in repeated testing or the need for alternative test methods. This recall is applicable to the 8164 and 8165 sets only.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets include: 1. 0864E4 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 2. 0864E5 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 3. 0864E7 Streptococcus agalactiae (Group B, lb) derived from ATCC 12401; 4. Negative Control 0243 Lactobacillus acidophilus derived from ATCC 4356
Where it was distributed
US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, NC, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI, WV, WY.
Nationwide ArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasLouisianaMassachusettsMarylandMinnesotaNorth CarolinaNew MexicoNew YorkOhioOregonPennsylvania
Questions about this recall
Why was it recalled?
The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164 Cepheid Xpert GBS QC Set and 8165 Cepheid Smart GBS QC Set was found to test positive for Group B Streptococcus (GBS) in some cases. This causes a failure when used as a quality control for the Cepheid Xpert GBS and Cepheid Smart GBS systems. The failure of the quality control test causes a disruption for the testing laboratory which may result in repeated testing or the need for alternative test methods. This recall is applicable to the 8164 and 8165 sets only.
Which lots are affected?
Catalog Number: 8165; Lot Number (Expiration Date): 8165-25 (06/16/2016); UDI: 70845357028630
Where was it sold?
US Nationwide distribution in the states of AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, MN, NC, NM, NY, OH, OR, PA, TN, TX, VA, VT, WA, WI, WV, WY.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 89517| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | QC Sets and Panels: Kwik-stik recalled by Microbiologics | Microbiologics | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Lyfo Disk, Campylobacter jejuni subsp recalled by Microbiologics | Microbiologics | Other Bacterial Contamination | Nationwide |
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| Device | CLASS II | Kwik-stik, Campylobacter jejuni subsp recalled by Microbiologics | Microbiologics | Other Bacterial Contamination | Nationwide |
| Device | CLASS II | Kwik-stik, Quality control kit for culture media recalled | Microbiologics | Packaging Defects | MN |
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