Diagnostic Control Microorganism Recalled for Incorrect Test Results
Diagnostic control microorganisms manufactured by Microbiologics Inc are recalled for returning incorrect antibiotic susceptibility test results. These controls failed quality specifications and could cause inaccurate lab test results.
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 a Class II medical device that failed internal quality specifications. While no illnesses or injuries have been reported, the product is a risk-of-harm device whose failure could lead to incorrect laboratory test results, meeting the rubric criterion for Score 3 (High).
Plain-English summary
LYFO-DISK Enterococcus faecalis derived from ATCC 51299 is an in vitro diagnostic control product manufactured by Microbiologics Inc. It is used as a reference standard in laboratory testing.
This product is being recalled because specific lots failed quality testing. When tested on the Vitek 2 AST-GP67 card, the High Level Gentamicin Synergy value was out of specification (sensitive). These same lots also failed the disk diffusion method used for product release testing. As a result, these controls may return incorrect susceptible results.
A total of 183 units have been distributed worldwide, including throughout the United States (including Puerto Rico and Guam), Australia, and many other countries.
Laboratories that have used the affected lots should review any susceptibility test results that relied on these controls for validation. The affected lot numbers are 959-94-1, 959-94-4, 959-95-3, 959-96-2, and 959-97-3, with expiration dates ranging from April 30, 2020 to March 31, 2021.
The recalled product
- Product
- LYFO-DISK Enterococcus faecalis derived from ATCC 51299 In Vitro Diagnostic Control microorganisms
- Manufacturer
- Microbiologics Inc
- Affected units
- 183
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 (7)
- Specific codes for Catalog Number 0959L
- UDI: 10845357023237
- Lot Number (Expiration Date): 959-94-1 (04/30/2020)
- 959-94-4 (04/30/2020)
- 959-95-3 (09/30/2020)
- 959-96-2 (12/31/2020)
- 959-97-3 (03/31/2021).
Distribution
Part of a larger recall action
This product is one of 5 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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