Reported Jun 12, 2019 · Ongoing
Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019,…
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?
- Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195)
- UDI70845357041226
- Product Usage
On April 92019
- Microbiologics sent ACTION REQUIREDMEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM indicating how much product they had on hand
- Lot codes and dates
- Cepheid Xpert MRSA/MRSA NxG Control
- Panel Catalog Number 8195 Lot Numbers8195-02, 8195-03, 8195-04, 8195-05, 8195-06, 8195-07, 8195-08, 8195-09, and 8195-10. Cepheid Xpert¿ SA Nasal Complete Control
- Panel Catalog Number 8196 Lot Numbers
8196-048196-058196-068196-078196-08 8196-098196-10and 8196-14
- Amount recalled
- 249
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Product with incorrect shelf life.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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