Fujifilm Medical Systems Recalls Potentially Defective Wako Chip Cassettes
Fujifilm Medical Systems is recalling 496 Wako Chip Cassettes because they may produce incorrect DCP and AFP-L3% measurement values.
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: The recall is classified as FDA Class II, and the hazard involves a risk of harm (incorrect diagnostic values) where specific injury or illness reports are not stated in the source text.
Plain-English summary
Fujifilm Medical Systems U.S.A., Inc. is recalling 496 units of the Wako Chip Cassette, which is part of the Wako i30 kit. The recall is due to a defect that may cause the device to produce incorrect DCP and AFP-L3% measurement values when used for these specific tests.
The affected units are identified by Lot Number EQ194 and have an expiration date of 05/31/2022. These units were distributed in California, Louisiana, Minnesota, North Carolina, Utah, and Wisconsin.
Healthcare facilities and consumers who possess these specific units should stop using them for DCP or AFP-L3% measurements and contact the recalling firm for further instructions.
The recalled product
- Product
- ¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
- Manufacturer
- Fujifilm Medical Systems U.S.A., Inc.
- Affected units
- 496
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 (1)
- Lot Number: EQ194 Exp. Date: 05/31/2022
Distribution
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