Microbiologics Inc: LYFO Disk

Is my product affected?

LYFO Disk

• UPC 10845357023930

Check against the official notice below — it lists the full affected range.

What happened

Microbiologics Inc. is recalling LYFO Disk Catalog #0983L, lot number 983-40-3, because the product labeled as Candida tropicalis actually contains Yersinia enterocolitica. This mislabeling error was distributed nationwide to three consignees in Colorado, Georgia, and Ohio, with 3 units affected. The lot number is 983-40-3 with an expiration date of 02/11/2016, and the UDI is 10845357023930.

The labeling error may cause users' quality control testing to fail, requiring them to repeat testing and potentially delaying test results. The source document does not specify what actions affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.

Details from the source

Reason for recall: LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results. Distribution: Distribution is nationwide with three consignees located in Colorado, Georgia, and Ohio. Quantity: 3 units Lot/code info: Catalog Number 0983L, UDI: 10845357023930, Lot Number (Expiration Date): 983-40-3 (02/11/2016)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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