LYFO-DISK Quality Control Kit Lot Fails Antibiotic Resistance Specification
A lot of LYFO-DISK quality control kit was found susceptible to Gentamicin Synergy when it should have been resistant. The 153 affected units were distributed worldwide.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—a specification failure in a quality control product could affect laboratory testing accuracy. The primary issue is manufacturing defect where product failed to meet documented antibiotic resistance specification.
Plain-English summary
Microbiologics Inc has recalled specific lots of LYFO-DISK, a quality control kit used in laboratory culture media validation. The product contains Enterococcus faecalis reference bacteria (ATCC 51299) with specified antibiotic resistance properties.
During in-house testing, one lot was found to be susceptible to Gentamicin Synergy when it should have been resistant to both Gentamicin and Gentamicin Synergy. This discrepancy means the kit would not perform as intended for quality control purposes. A total of 153 units across six lot numbers are affected.
The recalled product was distributed worldwide to the United States and 39 other countries. The affected lot numbers are 959-74-5, 959-74-8, 959-75-1, 959-75-5, 959-75-11, and 959-77-2, with expiration dates between October 2014 and October 2015.
Laboratories using these specific lots should discontinue use and contact Microbiologics Inc for replacement product. FDA classified this as a Class II recall.
The recalled product
- Product
- LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Enterococcus faecalis derived from ATCC 51299
- Manufacturer
- Microbiologics Inc
- Hazard
- specification-failure
- testing-accuracy
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 (8)
- Catalog Number 0959L
- UDI: 10845357023237
- Lot Number (Expiration Date): 959-74-5 (10/08/2014)
- 959-74-8 (10/08/2014)
- 959-75-1 (04/22/2015)
- 959-75-5 (04/22/2015)
- 959-75-11 (04/22/2015)
- and 959-77-2 (10/21/2015)
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27