¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Reported: April 21, 2021 Initiated: February 18, 2021 #Z-1412-2021
Product Description
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit
Reason for Recall
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Details
- Recalling Firm
- Fujifilm Medical Systems U.S.A., Inc.
- Units Affected
- 496 units
- Distribution
- CA, LA, MN, NC, UT, WI
- Location
- Lexington, MA
Frequently Asked Questions
What product was recalled? ▼
¿TASWako Chip Cassette is part of the Wako ¿TASWako i30 kit. Recalled by Fujifilm Medical Systems U.S.A., Inc.. Units affected: 496 units.
Why was this product recalled? ▼
Potentially defective Chip Cassette units, when used for DCP or AFP-L3% measurement, incorrect DCP and AFP-L3% values may result
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 21, 2021. Severity: Moderate. Recall number: Z-1412-2021.
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