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FDA (Device enforcement)Recalled 2022-03-03closedclass ii

Microbiologics Inc: Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bact

Is my product affected?

Pneumonia (33 Targets) Control Panel, unassayed quality control material, containing: Positive Control 1 - Semi-Quantitative Bacteria Positive Control 2 - Viruses and Atypical Bacteria

  • UPC 70845357043664

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

What happened

Microbiologics Inc. recalled its Pneumonia (33 Targets) Control Panel, a quality control material used in laboratories, because the product's actual shelf-life is 6 months rather than the labeled 18 months. The recall affects 13 units distributed across Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin. Two lot numbers are involved: Lot 8244 01 with an original expiration date of July 31, 2022 (corrected to July 26, 2021) and Lot 8244 02 with an original expiration date of August 31, 2022 (corrected to August 2, 2021).

The source document does not specify a remedy or what affected consumers should do in response to this recall.

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

Hazard

Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months.

Details from the source

Reason for recall: Shelf-life for the 8244 Pneumonia (33 Targets) Control Panel determined to be 6 months instead of 18 months. Distribution: US distribution to Alabama, Georgia, Illinois, Montana, Pennsylvania, Tennessee, Texas, and Wisconsin Quantity: 13 units Lot/code info: Catalog Number 8244, UDI: 70845357043664, Lot Number (Expiration Date) (New Expiration Date): 8244 01 (07/31/2022) (07/26/2021), 8244 02 (08/31/2022) (08/02/2021)

Source

Official record: FDA (Device enforcement) ↗

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

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