Microbiologics Recalls Cepheid Xpert MRSA Control Panels Due to Incorrect Shelf Life
Microbiologics Inc is recalling 249 units of Cepheid Xpert MRSA/MRSA NxG and Xpert SA Nasal Complete Control Panels because they have an incorrect shelf life.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as an incorrect shelf life (a labeling/documentation issue) and does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Microbiologics Inc is recalling 249 units of Cepheid Xpert MRSA/MRSA NxG Control Panels (Catalog #8195) and Cepheid Xpert SA Nasal Complete Control Panels (Catalog #8196). The recall was initiated because the products have an incorrect shelf life.
The affected products were distributed nationwide in the United States and in Australia, Chile, Germany, New Zealand, and the United Kingdom. The specific lot numbers involved are 8195-02 through 8195-10 for the MRSA/MRSA NxG panels, and 8196-04 through 8196-10 and 8196-14 for the Xpert SA Nasal Complete panels.
On April 9, 2019, Microbiologics sent emails to their direct US consignees requesting them to complete a Medical Device Correction Form indicating how much product they had on hand. Users should check their inventory for the specific catalog and lot numbers listed above and follow the instructions provided by the manufacturer.
The recalled product
- Product
- Cepheid Xpert MRSA/MRSA NxG Control Panel (Catalog #8195) UDI: 70845357041226 Product Usage: On April 9, 2019, Microbiologics sent ACTION REQUIRED: MEDICAL DEVICE CORRECTION emails to their direct US consignees requesting them to complete a MEDICAL DEVICE CORRECTION FORM…
- Manufacturer
- Microbiologics Inc
- Hazard
- Affected units
- 249
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 8195-03
- 8195-04
- 8195-05
- 8195-06
- 8195-07
- 8195-08
- 8195-09
- 8196-05
- 8196-06
- 8196-07
- 8196-08 8196-09
- 8196-10
- and 8196-14.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Microbiologics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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