The Recall Desk
ModerateFDA (Devices)·Z-0982-2019·Announced 2019-03-13

Cepheid Respiratory Control Panel Recalled for Reduced Expiration Date

Microbiologics Inc is recalling Cepheid Respiratory Control Panels because the expiration date was reduced from 24 months to 13 months.

What this means for you

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 describes a reduced expiration date without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving labeling or precautionary issues without reported harm.

Plain-English summary

Microbiologics Inc is recalling 704 units of the Cepheid Respiratory Control Panel, Catalog #8199, for in vitro diagnostic use. The recall was initiated because the product has a reduced expiration date, changing from 24 months to 13 months.

The affected products were distributed nationwide to 35 states and internationally to 11 countries, including Austria, Canada, Finland, Ireland, Malaysia, New Zealand, Portugal, South Africa, Sweden, Switzerland, and the United Kingdom. Specific lot numbers and expiration date changes are listed in the agency's structured data.

Healthcare facilities and laboratories should stop using the affected control panels and contact Microbiologics Inc for instructions on return or replacement. This recall addresses a labeling and stability issue regarding the product's shelf life.

The recalled product

Product
Cepheid Respiratory Control Panel Catalog #8199 for in vitro diagnostic use
Manufacturer
Microbiologics Inc
Category
Medical Device — In Vitro Diagnostics
Hazard
Affected units
704

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 (20)

  • Catalog Number 8199
  • Lot Number (original expiration date YYYY/MM/DD
  • new expiration date YYYY/MM/DD): 8199-02 (2019/02/28
  • 2018/03/31)
  • 8199-03 (2019/02/28
  • 8199-04 (2019/05/31
  • 2018/06/30)
  • 8199-05 (2019/05/31
  • 8199-06 (2019/10/31
  • 2018/11/30)
  • 8199-07 (2019/05/31
  • 8199-08 (2019/12/31
  • 2019/01/31)
  • 8199-09 (2019/05/31
  • 8199-10 (2020/01/31
  • 2019/02/28)
  • 8199-11 (2020/01/31
  • 8199-12 (2020/01/31
  • 8199-13 (2020/01/31
  • 8199-17 (2020/04/30

Distribution

Distributed nationwide across the United States.

The notice also names 37 states specifically:

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