The Recall Desk
ModerateFDA (Devices)·Z-1093-2017·Announced 2017-02-01

Acumedia Tryptic Soy Agar Recalled Due to Precipitate Formation

Acumedia is recalling Tryptic Soy Agar because precipitate may form in plates, potentially leading to inaccurate microbial counts.

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: The recall is classified as FDA Class II. The hazard is a quality defect (precipitate) that may lead to inaccurate test results, but there are no reports of injury, illness, or death.

Plain-English summary

Acumedia Manufacturers, Inc. is recalling Tryptic Soy Agar (PN 7100) in 500g, 2Kg, 10Kg, and 50Kg sizes. The recall affects 482 units distributed worldwide, including the United States, Canada, the UK, and other international locations.

The recall is due to the formation of a light precipitate in prepared plates. While the growth performance of the medium is not changed, the particulate matter may be misinterpreted as microbial growth in poured plates, leading to inaccurate counts.

Users should stop using the affected lots and contact Acumedia for instructions. The specific lots involved are 108166A, 108166B, and 108166C.

The recalled product

Product
Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
Affected units
482

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 (6)

  • 7100A Lot 108166C 7100B
  • Lot 108166B 7100C
  • Lot 108166A 7100D
  • Lot 108166A 7100CAR
  • lot 108166B 108-1
  • Lot 108166B

Distribution