Reported Mar 9, 2022 · Terminated
QC Sets and Panels
Microbiologics Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Microbiologics Inc · 200 Cooper Ave N · Saint Cloud, MN · 56303-4440
Is this the product you have?
QC Sets and Panels
4 of 4 products
| # | Product as published |
|---|---|
| 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 |
- Lot codes and dates
- Catalog Number8165
- Lot Number (Expiration Date)8165-25 (06/16/2016)
- UDI70845357028630
- Amount recalled
- 8 units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Microbiologics Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.