Oxoid Microbact Listeria kit may identify the incorrect organism
Oxoid, part of Thermo Fisher Scientific, is recalling one lot of the Microbact 12L Listeria identification kit because it may identify the incorrect organism.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: a pathogen identification kit may name the wrong organism, and no injuries are stated in the source.
Plain-English summary
Oxoid Microbact Identification Kits, Listeria 12L Kit, 20 Tests, a Listeria identification system, are being recalled. Two kits were distributed in Georgia and California. The FDA has classified this recall as Class II.
Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify an incorrect organism due to an inconclusive result from ambiguous colour reactions in wells.
Affected product carries UDI/DI 5032384127498 and lot number 4494873.
Laboratories can identify affected kits by the lot number and UDI above, and may contact the recalling firm for further information.
The recalled product
- Product
- OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
- Manufacturer
- Oxoid Australia Pty Limited
- Affected units
- 2
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 (2)
- UDI/DI 5032384127498
- Lot Number 4494873
Distribution
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