The Recall Desk
HighFDA (Devices)·Z-0698-2022·Announced 2022-03-09

QC Control Panels Fail Shelf Life Stability Test at 24 Months

Microbiologics QC control panels for bacterial diagnostic testing failed shelf life validation at 24 months. The 29 affected units were distributed across US states and internationally to Canada, UK, Australia, Belgium, and India.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of quality control materials without reported illness or injury. The hazard is that shelf life testing failed, indicating the control panels may not provide reliable results for diagnostic quality control purposes. This is a risk-of-harm scenario for a critical laboratory tool, but actual harm has not been reported.

Plain-English summary

Microbiologics Inc is recalling 29 units of BD MAX CT/GC/TV Verification and Control Panel (Catalog Number 8193, Lot Numbers 8193-04 and 8193-06). These QC control panels are used in diagnostic laboratory testing for bacterial culture confirmation.

The manufacturer identified that real-time shelf life testing failed at 24 months of storage. This means the control panels did not maintain their stability throughout the intended shelf life period, which could compromise their effectiveness for quality control purposes in diagnostic testing.

The affected units were distributed to laboratories throughout the United States, including Alaska, California, District of Columbia, Florida, Iowa, Idaho, Kansas, Louisiana, Maryland, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Virginia, Washington, and West Virginia, as well as to facilities in Australia, Belgium, Canada, India, and the United Kingdom.

Laboratories should verify whether they received units from the affected lots (8193-04 or 8193-06) and contact Microbiologics Inc for guidance on replacement or verification of materials.

The recalled product

Product
Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.
Manufacturer
Microbiologics Inc
Category
Medical Device — Diagnostic Quality Control
Hazard
  • shelf-life-failure
  • qc-control-failure

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 (4)

  • Catalog Number: 8193
  • Lot Number: 8193-04
  • 8193-06
  • UDI: 70845357041080

Distribution

Distributed nationwide across the United States.

Related recalls

Same category